• 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 E SERIES DEFIBRILLATOR

  • 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 E SERIES DEFIBRILLATOR Back to Search Results
Model Number E SERIES
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Cardiac Arrest (1762); Death (1802); Loss Of Pulse (2562)
Event Date 08/16/2016
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 confirm asystole on a male patient (age unknown) cardiac arrest, the device displayed an unknown "defib pad fault" message while using defib electrode pads. Complainant indicated that they obtained another device to confirm that the patient had expired. Complainant indicated that during subsequent testing, the malfunction was not duplicated.
 
Manufacturer Narrative
This follow up medwatch report is reporting the evaluation of the device. This follow up medwatch report is also correcting information submitted on the initial medwatch report. The device was returned to zoll medical corporation; the malfunction was observed during review of the device's activity log. However we were unable to determine if the reported event indicates a device malfunction. The device was put through extensive testing without duplicating the reported malfunction. It is noteworthy to mention the electrode pads used at the time of the reported event were not returned at this time for evaluation. The device passed the final test procedure, was recertified, and returned to the customer. Analysis for reports of this type has not identified an increase in trend.
 
Event Description
Complainant alleged that while attempting to confirm asystole on a male patient (age unknown) cardiac arrest, the device displayed "defib pad short" message while using defib electrode pads.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameE SERIES DEFIBRILLATOR
Type of DeviceE SERIES
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key5932230
MDR Text Key54048870
Report Number1220908-2016-02175
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberE SERIES
Device Catalogue NumberE SERIES
Other Device ID Number00847946011567
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/07/2016 Patient Sequence Number: 1
-
-