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

Model Number MODEL 100

Device Problem Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse li-ion battery in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.The zoll autopulse li-ion battery failure mode and serial number (b)(6) reported in this ccr are covered by capa 22-005.

Event Description

The customer reported that the autopulse platform (sn (b)(6)) did not initially power up with autopulse li-ion battery (sn (b)(6)).The customer removed the battery from the platform and re-inserted it two times to troubleshoot the issue, but the issue persisted.The battery was showing ¾ of the total charge.Later at the station, the customer re-tested the platform with the same battery and two other batteries.The autopulse platform powered on every time with no issue, and the initial problem was not reproduced.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.

Manufacturer Narrative

The autopulse li-ion battery (sn: (b)(6) will not be returned to zoll for investigation.The reported autopulse li-ion battery was replaced under sales order (so) #: (b)(4) as part of the recall.The customer acknowledged they had received the recall letter from zoll on november 04, 2022.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY, RECHARGEABLE
• 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: kim thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17367617
• MDR Text Key: 319480829
• Report Number: 3010617000-2023-00675
• Device Sequence Number: 1
• Product Code: MOQ
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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