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 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.

Event Description

During shift check, customer reported that the autopulse li-ion battery (serial #(b)(4)) did not power-on the autopulse platform.The battery was charged last week before the incident and the battery status showed four green leds illuminated prior to placing into the platform.Other autopulse li-ion batteries were able to power-on the platform.No patient involvement.

Manufacturer Narrative

The reported complaint of a fully charged autopulse li-ion battery (serial # (b)(4) did not power on the autopulse platform was confirmed.The returned battery failed charging in a known good multi chemistry charger.Four green lights were lit after the charge attempt.The battery was also tested in a known good autopulse platform and failed to power up the autopulse.No physical damage on the returned battery was observed during visual inspection.The battery archive was downloaded and reviewed.Based on the archive, the returned battery recorded several improper charging and maintenances.The returned battery was being pulled out from the charger during the conditioning cycle or before a complete charge.Early discharged resulted minimum operating voltage of the battery and caused cell under-voltage.In addition, the battery was left remained in the autopulse platform for about 10-12 days on multiple occasions in which resulted to depleted cells and caused bad cells conditioning.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." the investigation findings revealed that the probable cause of the reported issue was due to low level voltage and/or bad cells condition which was likely resulted from improper battery management.The returned battery is non-operational and will be scrapped.

• 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: 8293505
• MDR Text Key: 134909688
• Report Number: 3010617000-2019-00059
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• 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: 02/22/2019

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
• 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: 02/15/2019
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1