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

Model Number	MODEL 100
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the autopulse platform (sn (b)(4)) does not power on with four fully charged autopulse li-ion batteries (sn (b)(4)).The issue was observed intermittently.It is unknown where the problem occurred.However, patient use information was requested but no additional information was provided.Please see the following related mfr reports: mfr 3010617000-2022-00578 for autopulse platform sn (b)(4).Mfr 3010617000-2022-00587 for autopulse li-ion battery sn (b)(4).Mfr 3010617000-2022-00588 for autopulse li-ion battery sn (b)(4).Mfr 3010617000-2022-00589 for autopulse li-ion battery sn (b)(4).
Additional Manufacturer Narrative
Zoll has received the autopulse battery for investigation.The battery sn (b)(4) was tested with the returned autopulse platform (sn (b)(4)) and was able to power on the platform without any issue.Further investigation is pending.A follow-up report will be filed when the investigation has been completed.
Additional Manufacturer Narrative
The zoll autopulse li-ion battery failure mode and serial number (b)(6) reported in this ccr are covered by capa 22-005.Refer to the capa documentation for details on the failure mode description, technical root cause discussion, and corrective action plan.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Common Device Name: 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: 14484388
• Report Number: 3010617000-2022-00590
• Device Sequence Number: 4808429
• Product Code: MOQ
• UDI-Device Identifier: 00849111001861
• UDI-Public: 00849111001861
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: D163369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0752-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown