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

Model Number 8700-0752-01

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the product for investigation.A supplemental report will be filed when the investigation has been completed.

Event Description

As reported, during shift check, the autopulse platform screen panel displayed 'replace battery' message upon insertion of a fully charged autopulse li-ion battery (sn (b)(4)).The users did observed the battery status as fully charged on the autopulse multi chemistry charger prior insertion on the platform.No patient involvement.

Manufacturer Narrative

The reported complaint of "replace battery" error message upon insertion of a fully charged autopulse li-ion battery in an autopulse platform was not confirmed.The autopulse li-ion battery (sn (b)(4) passed charging in a known good multi chemistry charger and passed the test in a known good autopulse platform.However, based on the battery archive data review, it was identified that the battery was pulled out from the charger during the conditioning cycle or before it completed the charging.Early discharged resulted minimum operating voltage of the battery.Therefore, it was determined that user error may have attributed to the reported complaint.The autopulse power system user guide states: "after every use, at the beginning of a shift, or at least once every 24 hours, the battery in the autopulse should be replaced with a fully charged battery." during visual inspection, no physical damage was observed, and three amber lights were lit on incoming inspection.Historical complaints were reviewed for information related to the reported complaint and there was no previous complaint reported for autopulse battery with serial number (b)(4).

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7668878
• MDR Text Key: 113390438
• Report Number: 3010617000-2018-00697
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0752-01
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1