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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 Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that while attempting to monitor a patient (age & gender unknown), the device was unable to obtain an ecg signal via electrode pads. Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
 
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Brand NameX 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 Key12522802
MDR Text Key273082647
Report Number1220908-2021-03077
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K112432/P160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 09/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberX SERIES
Device Catalogue NumberX SERIES
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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