MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG, INC / ARJOHUNTLEIGH AB ROTOPRONE; BED, PATIENT ROTATION, POWERED

Device Problems Defective Device (2588); Output Problem (3005); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2021

Event Type  Injury  

Event Description

With the patient in the bed, the bed became non functional in the supine position.At first, it was giving a "rotating" alert when the patient was not rotating.A call to the help line guided us through the process to reboot however the bed became stuck in supine position again.Call was again placed to the rep who stated they could get a replacement bed.Patient was then shifted to an icu bed to wait for new bed.New bed arrived and is also malfunctioning with the patient in prone positioning at 62 degrees.Icu manager states beds often malfunction.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG, INC / ARJOHUNTLEIGH AB; 2349 w lake st; suite 250; addison IL 60101
• MDR Report Key: 12195852
• MDR Text Key: 262497278
• Report Number: 12195852
• Device Sequence Number: 1
• Product Code: IKZ
• 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: 07/14/2021

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?: Yes
• Device Operator: No Information
• 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: 07/14/2021
• Date Report to Manufacturer: 07/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA