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

Model Number 8900-0223-01

Device Problems Arcing (2583); Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Skin Discoloration (2074)

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.

Event Description

The complainant alleged while treat an (b)(6) year old male patient, the patient received burns from the electrode pads.Complainant indicated that the burn was first degree with no blistering.The patient was prescribed triamcinolone 0.1% ointment to apply twice daily for 2 weeks.

Manufacturer Narrative

The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.

• Brand Name: ELECTRODES, ONESTEP CPR, SINGLE, R SERIES
• Type of Device: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 8633315
• MDR Text Key: 145838420
• Report Number: 1218058-2019-00055
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016265
• UDI-Public: 00847946016265
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/26/2019,05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8900-0223-01
• Device Catalogue Number: 8900-0223-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2019
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 86