MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY, MAIH, 2.7 DIA, 7 FT, W/SWITCH, 100-240V, PAC; INTERNAL HANDLE

Model Number 1011-0141-03

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem No Patient Involvement (2645)

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 during biomed testing, the associated defibrillator failed to discharge using these internal handles.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The internal handles were returned to zoll medical australia and the customer's report was observed and attributed to the discharge button.The discharge button was caught in the "delivered (depression)" position, which prevented the handles from discharging.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ASSY, MAIH, 2.7 DIA, 7 FT, W/SWITCH, 100-240V, PAC
• Type of Device: INTERNAL HANDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 10672051
• MDR Text Key: 211107093
• Report Number: 1220908-2020-03187
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00847946022839
• UDI-Public: 00847946022839
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1011-0141-03
• Device Catalogue Number: 1011-0141-03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1