MAUDE Adverse Event Report: BIO-DETEK INCORPORATED CPR STAT*PADZ HVP MULTI-FUNCTION CPR ELECTRODES -; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	8900-0402
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device was unable to analyze.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The electordes were returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.The electrodes were tested on a simulator and were able to analyze shockable and non-shockable rhythms correctly, provide therapy and provide cpr feedback.A visual inspection of the electrodes found no dsicrepancies.The electrodes were scrapped after testing.It's important to note there was no information available on positioning of the electrode pads on the patient.The clinical data file was not available for review as part of this investigation.Analysis of reports of this type has not identified an increase in trend.

• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 16481023
• Report Number: 1218058-2023-00037
• Device Sequence Number: 3135842
• Product Code: MKJ
• UDI-Device Identifier: 00847946016319
• UDI-Public: 00847946016319
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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
• Operator of Device: Other
• Device Expiration Date: 12/03/2023
• Device Model Number: 8900-0402
• Device Catalogue Number: 8900-0402
• Device Lot Number: 4921A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown