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

Model Number 8700-0752

Device Problem Failure to Charge (1085)

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

The autopulse lithium ion battery was returned to zoll on (b)(6) 2017, for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

As reported, the multi chemistry charger (mcc) indicated the autopulse lithium ion battery (sn: (b)(4)) failed charge.Per customer, the issue occurred when the battery was placed in either bays of the mcc.Upon removing the battery from the mcc, the customer indicated the battery status indicator displayed 4 green leds; however, the battery does not power on the autopulse platform during shift check.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed during functional testing.The returned autopulse lithium ion battery (sn: (b)(4)) was unable to charge in a good known reference multi chemistry charger.However, a root cause of the issue could not be conclusively determined through these evaluation.Visual inspection was performed and no physical damage was observed.Review of the retrieved archive data found multiple temperature mismatch, reset (low battery, glitch), preserved mode and clock glitch ends on thermistor during charging.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 6884334
• MDR Text Key: 87864259
• Report Number: 3010617000-2017-00734
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

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
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: 09/19/2017
• Supplement Dates FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• 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