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

Model Number 8700-0752-01

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

The reported event of the autopulse li-ion battery (sn (b)(4)) was confirmed during functional testing and archive data review.The most possible root cause for the reported issue was due to the communication error cause by esd (electrostatic discharge) hit.Upon visual inspection, no physical damage was observed and four green lights were lit on incoming inspection.During functional testing, the battery passed charging in a known good multi chemistry charger and four green lights were lit after successful charging.However, when inserted in the autopulse platform, the battery status led's showed no led's intermittently and the platform displayed "replace battery" message.The archive data review showed that the battery recorded two front-side-bus communication errors after the load test and during the charging.The possible cause for this error is esd hit which caused the front-side-bus to interface with the host processor.

Event Description

As reported, during shift check, the user observed that the autopulse li-ion battery (sn (b)(4)) was fully charged and the battery status led showed 4 green led's.However, when inserted in the autopulse platform, the battery status led's showed no led's intermittently.No patient involvement.

• 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
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4085411030
• MDR Report Key: 8462611
• MDR Text Key: 140484497
• Report Number: 3010617000-2019-00290
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• 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: 03/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1