MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 111927

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 06/21/2021

Event Type  No Answer Provided  

Event Description

Pt sda for cardioversion.While pt recovering post cardioversion with nurse anesthetist and cardiology pa, i was called back into room by nurse tech stating cardiology pa stated smelling burnt flesh.Returned to pt bay and cardioversion pads were removed and there was a thin red curved line on proximal area where pad was located.Later ordered neosporin was applied.

• Brand Name: R SERIES DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 12273589
• MDR Text Key: 264949243
• Report Number: 12273589
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/20/2021

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?: No
• Device Operator: No Information
• Device Model Number: 111927
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1