• 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 DEFIBRILLATOR/PACEMAKER

  • 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 DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number MSERIES BI-PHASIC
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Information (3190)
Event Date 11/20/2017
Event Type  Malfunction  
Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

 
Event Description

Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), the device was unable to obtain an ecg signal via electrode pads. Complainant indicated that the clinician obtained another device to continue treating the patient. Complainant indicated that there was no adverse effect to the patient due to the reported malfunction. Complainant indicated that subsequent testing did not duplicate the reported malfunction.

 
Manufacturer Narrative

The device and electrode pads were returned to zoll medical corporation and the customer's report was not replicated or confirmed. The device was put through extensive testing without duplicating the report. The electrodes passed testing with no discrepancies found that would contribute to the customer's report. The device was recertified and returned to the customer. No trend is associated with reports of this type.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameM SERIES
Type of DeviceDEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key7101416
MDR Text Key94292508
Report Number1220908-2017-03049
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK990762
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/20/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/08/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberMSERIES BI-PHASIC
Device Catalogue NumberM SERIES
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/28/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2000
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-