MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES

Model Number 8900-0224-01

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 11/15/2022

Event Type  Injury  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.Please refer to the attached user medwatch report that zoll medical corporation has received.Please reference medwatch report number 1218058-2022-00153 for a similar report from the same customer.

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), after removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the patient subsequently sustained a blister.The customer was unable to provide additional information on the patient's injury.

Manufacturer Narrative

The complainant was contacted for return of the device.The device has not been returned to zoll for evaluation.

• Brand Name: ELECTRODES, ONESTEP COMPLETE, SINGLE, R SERIES
• Type of Device: ELECTRODE
• 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: 16026481
• MDR Text Key: 305927492
• Report Number: 1218058-2022-00154
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016272
• UDI-Public: 00847946016272
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 03/12/2024
• Device Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Device Lot Number: 1122F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other