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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER
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ZOLL MEDICAL CORPORATION X SERIES; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number X SERIES
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Patient Involvement (2645)
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 during biomed testing, the device was unable to detect the attached multi-function cable.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The device was returned to zoll medical corporation; the reported malfunction was observed and attributed to a system interconnect flex cable that was not properly seated.The cable was reseated to correct the reported problem.Analysis for reports of this type has not identified an increase in trend.
 
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Brand Name
X SERIES
Type of Device
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key9334845
MDR Text Key166768453
Report Number1220908-2019-03562
Device Sequence Number1
Product Code DRT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K112432/P160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberX SERIES
Device Catalogue NumberX SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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