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 Type  Injury  

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 monitor a patient (age & gender unknown), after removing the electrode pads, blistering was found on the patient's skin.Complainant indicated that the patient sustained blistering (considered 2nd and 3rd degree burns).Please reference medwatch report 1218058-2022-00138 for similar events reported from the same customer.

Manufacturer Narrative

The customer was contacted for return of the suspect product and indicated they were collecting the pads for return.However, the electrode pads have not been returned to zoll for evaluation at this time.Additionally, the customer clarified that these pads were only used for monitoring and no energy was delivered during the event.This claim is related to a suspected skin reaction to the pads.The design of the zoll onestep complete pads uses materials that has passed biocompatibility testing.This claim will be reopened when product has been received.

• 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: 15909003
• MDR Text Key: 304785355
• Report Number: 1218058-2022-00137
• 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: 11/11/2022

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 Model Number: 8900-0224-01
• Device Catalogue Number: 8900-0224-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 11/11/2022
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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