MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. QUIK-COMBO PATCHES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 124832

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 05/12/2023

Event Type  malfunction  

Event Description

Pt had a synchronized cardioversion in the operating room.Pt had one synchronized shock at 200 joules (was delivered 280 joules with impedance), when removing the quick combo patches- pt noted to have blotchy red circular mark under chest patch- no open areas or blisters, cool to touch, pt denies pain, dr aware and ordered silvadene ointment to the area and to be sent home with pt.Dr spoke with pt about small burn.Patches and packaging gathered- zoll defibrillator checked by biomed along with patches- all functioned properly when check per bio med.

• Brand Name: QUIK-COMBO PATCHES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; 11811 willows rd., n.e.; redmond WA 98052
• MDR Report Key: 17669578
• MDR Text Key: 322492254
• Report Number: 17669578
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 124832
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1