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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER

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ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number R SERIES
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2016
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
 
Event Description
Complainant alleged that while attempting to pace a patient (age & gender unknown) the device lost ecg signal. Complainant indicated that the clinician obtained another device to continue treating the patient. Complainant did not indicate that there was any adverse effect to the patient due to the reported 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. A review of the device's activity log found an occurrence of an "ecg lead off" message while attempting to pace. This is not an indication of a fault with the device, and is typically due to invalid impedance from the electrodes to the patient's skin. The electrodes were not returned for evaluation. The device was recertified and returned to the customer. No trend is associated with reports of this type.
 
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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 Key5915782
MDR Text Key54203392
Report Number1220908-2016-02071
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,Followup
Report Date 08/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2016
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
Other Device ID Number00847946017521
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2015
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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