• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZOLL MEDICAL CORPORATION M SERIES AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameM SERIES
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 & 271 mill road
chelmsford MA 01824
MDR Report Key7082334
MDR Text Key93725636
Report Number7082334
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
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 Received12/05/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM SERIES
Other Device ID NumberVERSION 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 FDA11/21/2017
Device Age14 YR
Event Location Hospital
Date Report to Manufacturer11/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/05/2017 Patient Sequence Number: 1
Treatment
CARDIAC DRUGS; OTHER, CPR; THE PATIENT WAS UNDERGOING CARDIAC RESUSCITATION.
-
-