MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODE ONESTEP CPR A/A GC

Model Number 8900-000254-05

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Information (3190)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the product 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 set of electrode pads to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The electrode pads were returned to zoll medical corporation and the customer report was not confirmed or observed.A visual inspection showed no presents of hair or skin, but there appeared to be some dried blood on the sternum pad.The pads were tested on a test device with a test multifunction cable to cpr adaptor and passed continuity testing.Retained sample testing of the electrodes did not yield any discrepancies.Review of the log showed a number of user advisories and intermittent ecg.No trend identified.

• Brand Name: ELECTRODE ONESTEP CPR A/A GC
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 11059856
• MDR Text Key: 224598604
• Report Number: 1218058-2020-00097
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

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 Expiration Date: 09/24/2022
• Device Model Number: 8900-000254-05
• Device Catalogue Number: 8900-000254-05
• Device Lot Number: 3920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1