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

Model Number	8700-0702
Medical Device Problem Codes	Device Stops Intermittently (1599); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the autopulse battery in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
It was reported that during device check the autopulse platform (s/n (b)(4)) stopped compressions after a few compressions displaying a "low battery level" error.This was while using a known fully charge nimh battery (s/n (b)(4)).The customer tried two additional known fully charged nimh batteries (s/n's (b)(4)) with the same result.There was no patient involved with this event.Refer to mdrs 3010617000-2016-00143, 3010617000-2016-00144 and 3010617000-2016-00171.
Additional Manufacturer Narrative
Three nickel metal hydride batteries (s/n (b)(4)) were returned to zoll (b)(4) for evaluation.Testing of the 3 batteries shows that the power on the 3 nimh batteries was below 1300 w indicating the battery's capacity is below its nominal run time and the battery should be exchanged with a fully charged battery.

• Brand Name: AUTOPULSE® NIMH BATTERY
• Common Device Name: LI-ION BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5487102
• Report Number: 3010617000-2016-00145
• Device Sequence Number: 601812
• Product Code: DRM
• UDI-Device Identifier: 00849111002042
• UDI-Public: 00849111002042
• 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,Followup
• Report Date (Section B): 05/17/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2016
• Supplement Report FDA Received Date: 05/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1