MAUDE Adverse Event Report: BIO-DETEK INCORPORATED STAT PADZ II ADULT MULTI-FUNCTION ELECTRODES; DEFIB/PACING ELECTRODES

Model Number	8900-0801-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while defibrillating a patient (age & gender unknown), after removing the electrode pads, burns were found on the patient.No further information was provided.Complainant indicated that the patient sustained burns.This is all the information available.
Additional Manufacturer Narrative
The customer has indicated the electrodes were not retained.Electrode labeling calls out the importance of good placement on the patient and provide instructions for proper electrode application technique.Poor adherence and /or air under the electrodes can lead to the possibility of arcing and skin burns.Good skin preparation does not guarantee a burn will not occur and burns from defibrillation is an expected risk.No trend is associated with reports of this type.

• Brand Name: STAT PADZ II ADULT MULTI-FUNCTION ELECTRODES
• Common Device Name: DEFIB/PACING ELECTRODES
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 8966566
• Report Number: 1218058-2019-00122
• Device Sequence Number: 2098976
• Product Code: MKJ
• UDI-Device Identifier: 00847946016326
• UDI-Public: 00847946016326
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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
• Operator of Device: Other
• Device Model Number: 8900-0801-01
• Device Catalogue Number: 8900-0801-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other