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

Model Number	8700-0752
Medical Device Problem Codes	Failure to Power Up (1476); Battery Problem (2885)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse battery was returned to zoll on 05/22/2017 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
It was reported that a fully charged autopulse lithium ion battery (b)(4) did not power on the autopulse platform during a shift check.The platform did power on when other autopulse batteries were used.There was no patient involvement.
Additional Manufacturer Narrative
The reported event was not confirmed during evaluation of the returned autopulse lithium ion battery (serial number: (b)(4)).No physical damages were observed during visual inspection and the battery was received fully charged.Review of the battery's archive data found no recorded errors on the reported date of event ((b)(6) 2017) or in the entire archive data.Additionally, the archive revealed the battery was last fully charged successfully on (b)(6) 2017 and was last inserted into an autopulse platform the same day without errors.Historical complaints were reviewed for information related to the reported complaint and there was no similar history of complaint reported for autopulse battery with serial number (b)(4).

• 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: 6615483
• Report Number: 3010617000-2017-00357
• Device Sequence Number: 16305934
• Product Code: DRM
• UDI-Device Identifier: 00849111065054
• UDI-Public: 00849111065054
• 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,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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
• Device Catalogue Number: 8700-0752-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1