MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION M SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number M SERIES

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Improper Device Output (2953); Noise, Audible (3273)

Patient Problems Chest Pain (1776); Loss of consciousness (2418)

Event Date 11/09/2017

Event Type  malfunction  

Event Description

A (b)(6) patient presented to the ed w/ complaints of chest pain.During triage, patient became unresponsive.Pt was placed on stretcher and cpr started.Pads were placed on the patient.Ventricular tachycardia was noted on the monitor.Staff charged the zoll defibrillator to shock the patient with the hands-free pads.Shock was initiated.Staff witnessed the patient to move with the shock and a loud popping noise was noted from the defibrillator.The staff also reported smelling smoke.The defibrillator was removed from the room and a new defibrillator placed.Care continued with the patient.The patient converted with a second shock.The rhythm strip that printed out at the time of the 1st shock noted a shock of 284 joules administered rather than the set 200 joules.No damage was noted to the pads and the pads were not removed at the time that the defibrillator was switched out.The defibrillator was evaluated by the clinical engineering department who reported "physical damage to the upper housing and to the defibrillator paddles." during the operational verifications, the defibrillator displayed the error code "defib fault 78." the explanation for this is "unable to charge defib cap." according to clinical engineering, the technical action would be to replace the high voltage module or capacitor.This evaluation would explain the failure descriptions reported by the ed staff member.The defibrillator was removed from service and will not be returned to service.

• Brand Name: M SERIES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 & 271 mill road; chelmsford MA 01824
• MDR Report Key: 7082334
• MDR Text Key: 93725636
• Report Number: 7082334
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: M SERIES
• Other Device ID Number: VERSION 39.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2017
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS; OTHER, CPR; THE PATIENT WAS UNDERGOING CARDIAC RESUSCITATION.
• Patient Age: 58 YR