IABP

Description of Event or Problem

IT WAS REPORTED THAT THERE WERE TWO BATTERIES THAT FAILED. THE SAMPLE IS AVAILABLE; HOWEVER, THERE IS CURRENTLY NO ADDITIONAL INFORMATION ON THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE UPDATED ACCORDINGLY.

Additional Manufacturer Narrative

(B)(4). THERE IS AN INVESTIGATION ONGOING INTO THIS REPORTED COMPLAINT. A SUPPLEMENT FOLLOW-UP MDR REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT THERE WERE TWO BATTERIES THAT FAILED. THE SAMPLE IS AVAILABLE; HOWEVER, THERE IS CURRENTLY NO ADDITIONAL INFORMATION ON THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE UPDATED ACCORDINGLY.

Additional Manufacturer Narrative

(B)(4). TELEFLEX RECEIVED THE DEVICE FOR INVESTIGATION. THE REPORTED COMPLAINT OF BATTERY FAILURE IS CONFIRMED. THE RETURNED BATTERIES FAILED THE BATTERY LOAD TEST. DURING THE COMPLAINT INVESTIGATION, THE PUMP SHUT OFF AFTER APPROXIMATELY 58 MINUTES WHEN OPERATING ON BATTERY POWER AFTER A FULL CHARGE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BUT A POTENTIAL CAUSE OF THE SHORT BATTERY LIFE IS A RESULT OF MAINTAINING OF THE BATTERY. IABP USERS AND SERVICERS MUST FOLLOW THE OPERATING INSTRUCTIONS MANUAL FOR RECOMMENDATIONS ON USAGE, CHARGING, MAINTENANCE AND STORAGE OF THE BATTERIES. IF BATTERY MAINTENANCE IS NOT PERFORMED PER THE IABP OPERATING INSTRUCTIONS MANUAL, THE BATTERY MAY NOT PROVIDE THE EXPECTED MINIMUM RUN TIME OF OPERATING POWER. THE SPECIFIC SERIAL NUMBER WAS NOT REPORTED, BUT A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR ALL THE LOT NUMBERS/SERIAL NUMBERS OF IABP'S AT THIS ACCOUNT WITH NO RELEVANT FINDINGS. ALL DEVICES PASSED MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. TELEFLEX ASSESSED THE RISK FOR THE REPORTED COMPLAINT. THERE ARE NO NEW OR REVISED RISK. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.