MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONESTEP CPR AA; ELECTRODE

Model Number	8900-0225-01
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that during biomed testing, the associated defibrillator was unable to detect the attached electrode pads.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The pads were returned to zoll medical united kingdom for evaluation.The customer's report was verified and attributed to a disconnected jumper wire (self test wire) on the electrode pad.This type of failure does not disable the electrode from delivering therapy when attached to a defibrillator.This is a malfunction which only impacts self-test of the electrode with the defibrillator.This type of malfunction does not pose any clinical impact and does not meet our guidelines for reportability.The pads were replaced.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ONESTEP CPR AA
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• Manufacturer Contact: tina lombari ; 525 narragansett park drive; pawtucket, RI 02861 ; 4017291400
• MDR Report Key: 20126308
• Report Number: 1218058-2024-00085
• Device Sequence Number: 18007992
• Product Code: MKJ
• UDI-Device Identifier: 00847946016289
• UDI-Public: (01)00847946016289(17)250730(10)3123
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P160022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 07/30/2025
• Device Model Number: 8900-0225-01
• Device Lot Number: 3123
• Was Device Available for Evaluation?: No
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2023
• 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