MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY, MAIH, 1.0 DIA, 7 FT, W/SWITCH, 100-240V, PAC; INTERNAL HANDLE

Model Number	1011-0141-01
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Death
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 defibrillate a patient (age & gender unknown) during surgery, the associated defibrillator failed to discharge using these internal handles.Complainant indicated that the patient subsequently expired; however they do not believe this was device associated.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Evaluation results: the set of internal paddles were not returned zoll medical corporation for evaluation.Instead, the service technician and hospital territory managers visited the customer's site.The customer indicated that the failure to discharge was due to the operator not being trained to use the device with internal huddles.Only appropriate trained, skilled personnel who are familiar with equipment operation should perform emergency defibrillation.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ASSY, MAIH, 1.0 DIA, 7 FT, W/SWITCH, 100-240V, PAC
• Common Device Name: INTERNAL HANDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 9268723
• Report Number: 1220908-2019-03310
• Device Sequence Number: 1849676
• Product Code: LDD
• UDI-Device Identifier: 00847946022716
• UDI-Public: 00847946022716
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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: 1011-0141-01
• Device Catalogue Number: 1011-0141-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death