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

Model Number 1011-0139-04

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 02/15/2019

Event Type  Death  

Manufacturer Narrative

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

Event 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.

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 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
• Type of Device: INTERNAL PADDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 8404977
• MDR Text Key: 138274300
• Report Number: 1220908-2019-00660
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00847946022358
• UDI-Public: 00847946022358
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: 1011-0139-04
• Device Catalogue Number: 8011-0139-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/08/2019
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death