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

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event 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.

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
• Type of Device: INTERNAL HANDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 10736397
• MDR Text Key: 213079341
• Report Number: 1220908-2020-03341
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00847946022327
• UDI-Public: 00847946022327
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1