MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY, MODULE, BATTERY PACK 4410; RECHARGEABLE BATTERY PACK

Model Number	1001-0144
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Tinnitus (2103); Total Hearing Loss (4473)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that a battery charge was to be carried out with the associated charging station.When inserting the battery into the charging station, which was already under power, there was a loud bang and the cap, which was attached to the battery, came loose and flew off.Complainant indicated the employee suffered hearing loss and tinnitus on both sides.The employee was then seen by an ear nose and throat specialist.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the battery and the customer's report was not replicated or confirmed.The returned battery was confirmed to be damaged, with the cells exposed and the top cover separated.The battery cells have no signs of damage or evidence that suggests the cells vented, or leaked.There is not enough evidence to confirm the report.The battery was scrapped and replaced.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ASSY, MODULE, BATTERY PACK 4410
• Common Device Name: RECHARGEABLE BATTERY PACK
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 14115602
• Report Number: 1220908-2022-01345
• Device Sequence Number: 5932875
• Product Code: MKJ
• UDI-Device Identifier: 00847946016678
• UDI-Public: 00847946016678
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 1001-0144
• Device Catalogue Number: 8000-0299-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown