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

Model Number	8700-0752-08
Medical Device Problem Codes	Battery Problem (2885); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse li-ion battery in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
As reported, the user inserted a fully charged (four green leds displayed on the battery status indicator) autopulse li-ion battery (b)(4) in an autopulse platform, and the platform displayed a "replace battery" message.The battery, prior to platform insertion, was checked and the battery status indicator displayed four green leds (fully charged).The issue was observed during routine check and no patient was involved.It was further reported that following the event, the user tested the battery by charging it in an autopulse multi chemistry charger and the battery was unable to charge.The user stated that they maintain a regular battery rotation.Additionally, the platform was also tested by inserting another autopulse li-ion battery and operated as intended without any fault observed.

• 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: 7009515
• Report Number: 3010617000-2017-00882
• Device Sequence Number: 1184775
• Product Code: DRM
• UDI-Device Identifier: 00849111001847
• UDI-Public: 00849111001847
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2017

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: 8700-0752-08
• Device Catalogue Number: 8700-0752-08
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1