Rottweil, Den 23

Metrax GmbH • Postfach 1553 • D-78615 Rottweil

Important safety about PRIMEDIC™ AkuPak

Metrax reference number: MIN10013

Dear Sir/Madam,

We wish to inform you about a problem with the storage battery of PRIMEDICTM AkuPak 73765. Due to an error in the software and in the configuration file of PRIMEDIC™ AkuPak 73765, an incorrect battery charge status may result in the equipment switching over to an unexpected 'power-off' state during an emergency treatment. All the information regarding this customer bulletin is also available on the internet at www.min.heartsave.de.

Affected storage batteries Metrax GmbH has identified the affected storage batteries worldwide. All the affected PRIMEDIC™ AkuPak 73765 with their respective serial numbers are listed in the annexure to this letter. Until now, no incident has been reported to us in connection with this problem.

Cause of the equipment behaviour Due to an error in the software, the self-discharge counter of PRIMEDIC™ AkuPak 73765 is reset during connecting it to a defibrillator. Self-discharge counter analyses the chemical discharge of a storage battery during the period the defibrillators not in operation. This can result in the fact that the available capacity of the storage battery is displayed incorrectly despite longer duration of charging and, at times, the storage battery may not be immediately charged. Further, incorrect default value for the self-discharge rate is entered in the configuration file. Similarly this can lead to incorrect display of charge status in case of long period of storage.

Risk When not connected to the equipment, storing the storage battery over very long period without the likelihood of recharging (approximately 10 weeks) it is possible that the storage battery displays residual charge although it is completely discharged. In such a case, display on the screen as well as on the integrated load status indicator would be false. This perhaps may lead to starting the equipment, however in case of high-voltage charge the equipment would turn off as a measure of abundant caution as a result of having reached the safety limit and any therapy would not be possible. Both these faults may result in the equipment turning off unexpectedly during an emergency treatment.

Metrax GmbH Phone: + 49 (0)741 257-0 Geschäftsführer: Jürgen Bucher Postbag 15 53 Fax: + 49 (0)741 257-265 Commercial register, district court at Stuttgart Rheinwaldstraße 22 Email: [email protected] HRB 470187  ILN 4007693000009 78628 Rottweil Internet: http//www.primedic.com Ust-IdNr.: DE811245037

Metrax GmbH • Postfach 1553 • D-78615 Rottweil

Remedy Software update of the affected storage batteries with new software and configuration file. This can be carried out only by Metrax Service. Therefore it is necessary that the affected storage batteries are returned to Metrax. Further use of the storage battery must be prevented. Software update is free of charge provided the storage battery reached Metrax before 01.04.2011t. Thereafter update will be on chargeable basis. Kindly contact our sales representatives in this matter:

Mr. Tobias Mohry Tel. +49 741 257-237 Fax: +49 741 257-235 Email: [email protected]

Mr. Jürgen Claßen Tel. +49 741 257-231 Fax: +49 741 257-235 Email: [email protected]

Metrax GmbH Rheinwaldstraße 22 78628 Rottweil Germany

Contact Metrax GmbH Central Office: +49 (0) 741 - 257 - 0 Fax: +49 (0) 741 - 257 - 235 e-mail: [email protected]

Yours sincerely,

Metrax GmbH

for Dirk Warnack Safety officer for medical devices pursuant to §30 (2) Medical Device Act, MPG