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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP CPR AA, SINGLE
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BIO-DETEK INCORPORATED ELECTRODES, ONESTEP CPR AA, SINGLE Back to Search Results
Model Number 8900-0225-01
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 the electrodes padz of the associated defibrillator would not connect to the multi-function cable.Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
Manufacturer Narrative
The onestep electrode pads were returned to zoll medical corporation.The customer's report was not replicated or confirmed.The pads were put through extensive testing using a know good device and multifunction cable without duplicating the report.The pad connector was inspected and no discrepancies were found.The pads were scrapped.Analysis of reports of this type has not identified an increase in trend.
 
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Brand Name
ELECTRODES, ONESTEP CPR AA, SINGLE
Type of Device
ELECTRODE
Manufacturer (Section D)
BIO-DETEK INCORPORATED
525 narragansett park drive
pawtucket RI 02861
MDR Report Key12283192
MDR Text Key267222233
Report Number1218058-2021-00102
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00847946016289
UDI-Public00847946016289
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/03/2022
Device Model Number8900-0225-01
Device Catalogue Number8900-0225-01
Device Lot Number4920B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2021
Was the Report Sent to FDA? No
Date Manufacturer Received07/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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