MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE LI-ION BATTERY; COMPRESSOR, CARDIAC, EXTERNAL

Model Number 8700-0752

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse li-ion battery for investigation.A supplemental report will be filed when the product is returned and the investigation has been completed.

Event Description

During shift check, the customer reported that the autopulse platform displayed a "replace battery" message upon insertion of the autopulse li-ion battery (sn (b)(4)).The crew did observe the battery was fully charged prior to insertion by pressing the status button.No patient involvement.

Manufacturer Narrative

The battery passed charging in a known good multi-chemistry charger and powers up a known good autopulse platform with a full battery status bar, not confirming the customer complaint.No physical damage was observed and four green lights were lit on incoming inspection.The battery archive was downloaded and reviewed.There were no errors recorded in the whole archive.The battery was last charged successfully on (b)(6) 2019.On (b)(6) 2019, the customer inserted/used the battery in the autopulse, let the battery remains in the platform for about a day and battery recorded one or more of its cells were slightly discharged.On (b)(6) 2019, the battery was inserted in the mcc to charge but charging was cancelled after few seconds.Apparently, the battery was pulled out during the conditioning cycle.On (b)(6) 2019, the battery was inserted in the autopulse platform five times for about a few seconds without charging it first and recorded one or more of its cells were slightly discharged.This battery is working fine as intended for use.The cause for this battery failure, based on the review of the battery is the battery was not reconditioned and fully charged prior to use.

• Brand Name: AUTOPULSE LI-ION BATTERY
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 9454918
• MDR Text Key: 178665556
• Report Number: 3010617000-2019-01116
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0752
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1