MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LI-ION BATTERY

Model Number	8700-0702
Medical Device Problem Code	Low Battery (2584)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse battery (b)(4) was evaluated at azm zoll (b)(6) on (b)(6) 2016.During the visual inspection, no physical damage was observed.In summary, when the battery was received for evaluation it showed green led status, indicating it was fully charged.The battery was placed in an autopulse and the autopulse battery indicator/icon showed the battery was fully charged.The battery was then placed in a multi-chemistry charger (mcc), which showed it was fully changed.The battery was tested again with another mcc, without issue.Based on the testing results, no problems found and it was determined that the battery works as intended.
Event or Problem Description
It was reported that during a shift check the autopulse battery (b)(4) showed low battery level while being tested in the autopulse platform.However the autopulse battery indicator showed "green" led (meaning a full battery).To troubleshoot the issue the platform was tested with other batteries without issue.The battery (b)(4) was re-tested the following day and the same problem occurred.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Common Device Name: LI-ION BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5734231
• Report Number: 3010617000-2016-00464
• Device Sequence Number: 13581028
• Product Code: DRM
• UDI-Device Identifier: 00849111065030
• UDI-Public: 00849111065030
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8700-0702
• Device Catalogue Number: 8700-0702-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2016
• Initial Report FDA Received Date: 06/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1