• 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 Mechanics Altered (2984)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has received the device and will be providing a supplemental report when our investigation is completed.
 
Event Description
Complainant alleged that during an incoming inspection , the device powered up in the incorrect mode. Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The device was returned to zoll medical corporation; the malfunction was duplicated and attributed to a system interconnect cable was not seated properly at the connector. The cable was reseated to correct the reported problem. The device was recertified and returned to the customer. Analysis for reports of this type has not identified an increase in trend.
 
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 Key8818261
MDR Text Key151939952
Report Number1220908-2019-02026
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060559/P160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberR SERIES
Device Catalogue NumberR SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-