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

Model Number MODEL 100

Device Problems Smoking (1585); Use of Device Problem (1670); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the battery, but the investigation still in process.A follow-up report will be submitted when the investigation has been completed.

Event Description

It was reported that the autopulse li-ion battery (sn (b)(4)) overheated in the multi-chemistry battery charger (mcc), this resulted in the battery smoking and melting in the mcc charger bay.A smoke detector went off which alerted the customer.No patient involved.

Manufacturer Narrative

The customer reported event of 'autopulse li-ion battery (sn (b)(4)) overheat smoking and melting in the multi-chemistry battery charger (mcc) bay' was confirmed during visual inspection.The most probable root cause was due to a conductive particle within the case (solder splash, broken component, metallic particle) and shorted critical circuit component pads and/or moisture from condensation which triggered a voltage breakdown between adjacent ~high voltage circuitry/parts on the pc board.During visual inspection the battery was found to be burned, thus confirming the customer's complaint.There were no signs of water ingress found inside the battery.Functional testing or review of archive data, was not possible due to the returned state of the burned battery.

• 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: 8858010
• MDR Text Key: 153202749
• Report Number: 3010617000-2019-00639
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• PMA/PMN Number: D163369
• 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: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0702-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2019
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1