MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY,MAIH, 3.0 DIA, W/SWITCH, 100-120VONLY; INTERNAL PADDLE

Model Number	1011-0139-04
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Codes	Death (1802); No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Zoll medical corporation has not received the product 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 internal handles failed to discharge.Complainant indicated that the clinician obtained another set of internal handles to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
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: the customer was contacted for return of the suspect product.The customer has responded and indicated the product will not be returning to zoll.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the internal handles failed to discharge.Complainant indicated that the ed team had opened the chest of a trauma patient with multiple gun-shot wounds.The patient was in ventricular fibrillation.Cardiac massage was ongoing, along with massive blood transfusion.Complainant indicated that the clinician obtained another set of internal handles to continue treating the patient.Complainant indicated that the patient subsequently expired.

• Brand Name: ASSY,MAIH, 3.0 DIA, W/SWITCH, 100-120VONLY
• Common Device Name: INTERNAL PADDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8404977
• Report Number: 1220908-2019-00660
• Device Sequence Number: 1811092
• Product Code: LDD
• UDI-Device Identifier: 00847946022358
• UDI-Public: 00847946022358
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/15/2019

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?: Yes
• Operator of Device: Other
• Device Model Number: 1011-0139-04
• Device Catalogue Number: 8011-0139-04
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 05/13/2019
• 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