MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY, MAIH, 1.0 DIA,W/SWITCH, 100-120V ONLY, PACKA; INTERNAL HANDLE

Model Number	1011-0139-01
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the associated defibrillator failed to discharge using these internal handles.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical canada 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 multiple shock testing without duplicating the report.The internal handles were returned to the customer.No trend is associated with reports of this type.An internal inspection resulted in no findings.

• Brand Name: ASSY, MAIH, 1.0 DIA,W/SWITCH, 100-120V ONLY, PACKA
• Common Device Name: INTERNAL HANDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 10736397
• Report Number: 1220908-2020-03341
• Device Sequence Number: 14514788
• Product Code: LDD
• UDI-Device Identifier: 00847946022327
• UDI-Public: 00847946022327
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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: 1011-0139-01
• Device Catalogue Number: 1011-0139-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1