MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY,M AIH, 1.6 DIA, W/SWITCH, 100-120V ONLY, PACK; INTERNAL HANDLE

Model Number	1011-0139-02
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the associated device failed to discharge using these internal handles.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the internal handles and the customer's report was not replicated or confirmed.The internal handles were put through extensive testing including full functional testing and shock testing at multiple joule settings without duplicating the report.The internal handles were scrapped.The device was recertified and returned to the customer.No trend is associated with reports of this type.

• Brand Name: ASSY,M AIH, 1.6 DIA, W/SWITCH, 100-120V ONLY, PACK
• Common Device Name: INTERNAL HANDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 11529529
• Report Number: 1220908-2021-00761
• Device Sequence Number: 3148066
• Product Code: LDD
• UDI-Device Identifier: 00847946022334
• UDI-Public: 00847946022334
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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: Other
• Device Model Number: 1011-0139-02
• Device Catalogue Number: 1011-0139-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1