MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ONESTEP CPR AA; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 8900-0225-01

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

Patient Problems Cardiac Arrest (1762); Skin Tears (2516)

Event Date 09/01/2021

Event Type  malfunction  

Event Description

Open wounds on patient's chest after use of zoll onestep pads when patient arrested.Nursing staff believed wounds were from the pads.Patient expired as outcome of code but not related to the wounds.Provider reported the skin damage was related to the patient having to be treated with steroids.States the patient's skin was friable and high risk for sluffing and that the skin damage appeared to be from shearing, not burns.

• Brand Name: ONESTEP CPR AA
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 269 & 271 mill road; chelmsford MA 01824
• MDR Report Key: 12827590
• MDR Text Key: 280951032
• Report Number: 12827590
• 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: 11/16/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 8900-0225-01
• Device Catalogue 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: 11/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25550 DA
• Patient Sex: Female
• Patient Weight: 85 KG