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

Model Number 8900-0225-01

Device Problems Sparking (2595); Patient Device Interaction Problem (4001)

Patient Problem Skin Tears (2516)

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 treat a (b)(6) year-old female patient, skin tearings were caused when the electrodes would not adhere to the patient's skin and were sliding around on the patient's skin.At one point there was a visible spark seen from the electrode pads.Complainant indicated that the patient subsequently sustained skin tearing.

Manufacturer Narrative

The customer was contacted for return of the suspect product.The customer has responded and indicated the product was discarded and will not be returning to zoll.It is noteworthy to mention the instructions for use for these electrodes indicate "poor adherence and/or air under the electrodes can lead to the possibility of arching and skin burns".In addition, the user is instructed to not conduct manual compressions through the electrodes at is may cause damage to the electrodes that may lead to the possibility of arcing and skin burns.Should the patient be repositioned it is also recommended the electrodes be pressed down to ensure good coupling.

• Brand Name: ELECTRODES, ONESTEP CPR AA, SINGLE
• 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: 12865130
• MDR Text Key: 281205307
• Report Number: 1218058-2021-00135
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946016289
• UDI-Public: 00847946016289
• 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: 11/03/2021

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: 8900-0225-01
• Device Catalogue Number: 8900-0225-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 01/13/2022
• 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
• Patient Age: 68 YR
• Patient Sex: Female