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

Model Number 1011-0139-04

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem Death (1802)

Event Date 07/09/2015

Event Type  Death  

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 female patient (age unknown), after successfully discharging three shocks to the patient, the associated device failed to discharge using these internal handles.Complainant indicated that the patient subsequently expired, however it was not a result of the reported malfunction.

Manufacturer Narrative

This report was inadvertently submitted as a duplicate.The reported event was originally reported under medwatch 1220908-2015-01952.Please refer to medwatch report 1220908-2015-01952 for the investigation results.This is being closed as a duplicate report.

• Brand Name: ASSY,MAIH, 3.0 DIA, W/SWITCH
• 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: 5194716
• MDR Text Key: 30050901
• Report Number: 1220908-2015-02844
• Device Sequence Number: 1
• Product Code: LDD
• 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: 10/14/2015

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
• Device Operator: Other
• Device Model Number: 1011-0139-04
• Device Catalogue Number: 1011-0139-04
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 11/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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