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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 Consequences Or Impact To Patient (2199)
Event Date 09/09/2019
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 treat a patient (age & gender unknown), the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
 
Manufacturer Narrative
The device was returned to zoll medical (b)(4) and the device performed to specification.The device was put through extensive testing including a visual inspection and functionally tested on a defib simulator without duplicating the report.The multi-function receptacle was replaced as a precaution.The device was recertified and returned to the customer.Review of the device activity logs did show the device was powered into manual mode with pads attached via a cpr adaptor.The ecg waveform can clearly be seen while the device is in the pads view for the first 6 seconds of the case.The device is then cycled into lead ii view, which does cause the ecg data to drop from the display.Cpr compressions are then performed, the pads are then disconnected from the adaptor and plugged back in 5 seconds later.The ecg waveform is once again visible as the device was switched to the pads view and remained visible for the entirety of the case.The customer's report of continuously switching from leads iii view to pads is not supported in the logs, which only shows one cycle change to leads view was performed.None of the accessories used were returned for evaluation as part of this investigation.Analysis of 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 Key9194008
MDR Text Key162441473
Report Number1220908-2019-03161
Device Sequence Number1
Product Code DRT
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 Other
Type of Report Initial,Followup
Report Date 09/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
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? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/24/2019
Initial Date FDA Received10/15/2019
Supplement Dates Manufacturer Received09/24/2019
Supplement Dates FDA Received11/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2018
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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