• 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 R SERIES DEFIBRILLATOR 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 R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number R SERIES
Device Problem Poor Quality Image (1408)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation evaluated the device and the reported malfunction was not replicated or confirmed. The device was put through extensive testing without duplicating the malfunction. The device's lcd color display cable was replaced as a precaution. The device was recertified and returned to the customer. No trend is associated with reports of this type.
 
Event Description
Complainant alleged that during a routine shift check by a clinician, the device's display was distorted and clinical information could not be seen. Complainant indicated that there was no patient involvement in the reported malfunction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameR SERIES DEFIBRILLATOR
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 Key5980626
MDR Text Key55807846
Report Number1220908-2016-02344
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060559
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 09/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberR SERIES
Device Catalogue NumberR SERIES
Other Device ID Number00847946002336
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-