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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODE ONESTEP CPR A/A GC, SINGLE
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BIO-DETEK INCORPORATED ELECTRODE ONESTEP CPR A/A GC, SINGLE Back to Search Results
Model Number 8900-000251-05
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Patient Involvement (2645)
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 during biomed testing, the associated the device was unable to obtain an ecg signal via attached electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
Zoll medical corporation evaluated the electrode pads and the reported malfunction was not replicated or confirmed.The electrode pads was put through extensive testing without duplicating the malfunction.Retained samples of the same lot number 2318 were investigated.Evaluation of the electrodes did not reveal any irregularities that would have contributed to the reported event.No trend is associated with reports of this type.
 
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Brand Name
ELECTRODE ONESTEP CPR A/A GC, SINGLE
Type of Device
ELECTRODE
Manufacturer (Section D)
BIO-DETEK INCORPORATED
525 narragansett park drive
pawtucket RI 02861
MDR Report Key8552516
MDR Text Key143426957
Report Number1218058-2019-00038
Device Sequence Number1
Product Code DRX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/04/2020
Device Model Number8900-000251-05
Device Catalogue Number8900-000251-05
Device Lot Number2318
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2019
Was the Report Sent to FDA? No
Date Manufacturer Received04/04/2019
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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