MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ONESTEP CPR AA; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 8900-0225-01

Patient Problems Cardiac Arrest (1762); Full thickness (Third Degree) Burn (2696); Syncope/Fainting (4411)

Event Date 03/25/2023

Event Type  Injury  

Event Description

Patient admitted with syncopal episode, cardiac arrest in the ed and transcutaneous pacer applied.Transcutaneous pacing used from the evening until next day mid-afternoon (approximately 18 hours of pacing).Patient sustained left chest full thickness burn from pacing pad.Required excision of the bone chest wall and rotation flap closure.Upon review, users were unaware that manufacturer recommends replacing pacer pads after 8 hours of pacing.Use of tpa prolonged the need for transcutaneous pacing.

• Brand Name: ONESTEP CPR AA
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 17548644
• MDR Text Key: 321151954
• Report Number: 17548644
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2023,06/16/2023

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 Model Number: 8900-0225-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 28105 DA
• Patient Sex: Female
• Patient Race: White