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 Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

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

As reported, the autopulse li-ion battery (sn (b)(4)) does not hold charge.The user tested the battery in the autopulse platform and the platform did not power on.The autopulse platform powered on and functioned normally using other autopulse li-ion batteries.No consequences or impact to patient information was available.

Manufacturer Narrative

The reported complaint of "the autopulse li-ion battery (sn (b)(4)) does not hold charge and doesn't power up the autopulse platform" was confirmed during the functional testing and archive data review.The root cause for the failure was due to the damaged field effect transistor (fet) caused by electrostatic discharge (esd) exposure.Upon visual inspection, no physical damaged was observed and four green lights were lit on incoming inspection.The battery failed charging in a known good autopulse multi-chemistry battery charger (mcc).The battery was also tested in a known good autopulse platform and the battery failed to power up the platform.The battery archive data showed that the battery recorded a repeated cell over-voltage detected errors from start to the end of the archive followed by a multiple preserved mode with possible one or more battery cells discharged below 2.0 volts and clock glitch.The common cause of the repeated over-voltage was due to esd where the bleed-fet gets damaged 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
• 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: 8485415
• MDR Text Key: 141018267
• Report Number: 3010617000-2019-00326
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

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: 04/29/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 05/17/2019
• Supplement Dates FDA Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2017
• 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