MAUDE Adverse Event Report: BIO-DETEK INCORPORATED CPR STATPADZ HVP MULTI-FUNCTION CPR ELECTRODES

Model Number	8900-0402
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the associated device was unable to obtain an ecg signal with these electrode pads.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation evaluated the electrode pads and the customer report was not replicated or confirmed.The investigation did not yield any results that were untypical.The electrodes passed all testing and were confirmed to have been assembled correctly.There is no indication of a device malfunction associated with the returned electrodes.Visual inspection of the pads did find samples of human hairs, skin residue, and a large piece of skin tissue that can prevent the electrodes from optimal coupling.The returned electrodes were observed to be functioning as expected during the evaluation.It is important to mention the device and activity/clinical logs were not returned for evaluation.No trend is associated with reports of this type.

• Brand Name: CPR STATPADZ HVP MULTI-FUNCTION CPR ELECTRODES
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 9519681
• Report Number: 1218058-2019-00177
• Device Sequence Number: 595478
• Product Code: MKJ
• UDI-Device Identifier: 00847946016319
• UDI-Public: 00847946016319
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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
• Operator of Device: Other
• Device Expiration Date: 04/09/2020
• Device Model Number: 8900-0402
• Device Catalogue Number: 8900-0402
• Device Lot Number: 1518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1