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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse li-ion battery (sn (b)(6)) involved in the reported complaint was not returned to zoll san jose for investigation because of the extensive damage.However, the reported complaint of the battery was damaged with two penetrating holes during the charging attempt, and smoke blackened the left bay of the autopulse multi-chemistry battery charger (mcc) (sn (b)(6)) was confirmed based on the returned mcc and the battery pictures provided by zoll china.The potential root cause of the reported complaint could be the aging battery (4.7 years old) sustained damage (impact) at some point and began malfunctioning, causing the cells to overheat and get damaged.
Additional Manufacturer Narrative
Zoll has not received the autopulse li-ion battery for investigation.A follow-up report will be submitted if and when the product is returned, and the investigation has been completed.
Event or Problem Description
The customer reported that after 30 minutes of placing the autopulse li-ion battery (sn (b)(6)) into the autopulse multi-chemistry battery charger (mcc) (sn (b)(6)) for charging, the battery was damaged with two penetrating holes.The battery's status leds showed no lights.Smoke blackened the left bay of the mcc.Besides smoke traces, the mcc had no damage and functioned as intended.No patient involvement.

• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19448858
• Report Number: 3010617000-2024-00438
• Device Sequence Number: 8567433
• Product Code: DRM
• UDI-Device Identifier: 00849111001915
• UDI-Public: 00849111001915
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112998
• 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): 06/13/2024

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: 8700-0752-15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2019
• 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