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 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse li-ion battery (sn (b)(4)) 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 autopulse li-ion battery (sn (b)(4)) status led showed green leds, however, the battery failed to power up the autopulse platform.No patient involvement.

Manufacturer Narrative

The reported complaint of "the autopulse li-ion battery (sn (b)(4) status led showed green leds, however, the battery failed to power up the autopulse platform" was confirmed during the functional testing and the archive data review.The root cause for the reported complaint was due to a damaged field effect transistor (fet) caused by electrostatic discharge (esd).Upon visual inspection, no physical damage was observed and three amber lights were lit during the incoming inspection.The battery failed to charge in a known good autopulse multi-chemistry battery charger and four green lights were lit after the charging attempt.The archive data review showed that the battery recorded a repeated cell over-voltage detected error messages followed by cell under-voltage, bad cell, battery reset and multiple in-out device event during each charged attempts.The most common cause for the repeated over voltage was due to damaged bleed-fet (field effect transistor) caused by esd (electrostatic discharge) causing the battery cells to leak and drain.

• 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: 8654767
• MDR Text Key: 147306456
• Report Number: 3010617000-2019-00447
• 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: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• 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: 06/03/2019
• Date Manufacturer Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1