MAUDE Adverse Event Report: ARJO ARJO; ROTOPRONE THERAPY SYSTEM

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2020

Event Type  malfunction  

Event Description

Staff attempted to switch the rotoprone bed to supine position, however, it seems that there was a malfunction of the rotoprone bed, "stuck" at a 90 degree angle, with pt lying on his left side for about 6-7 minutes.

• Brand Name: ARJO
• Type of Device: ROTOPRONE THERAPY SYSTEM
• Manufacturer (Section D): ARJO ; 2349 w. lake street; ste 250
• MDR Report Key: 10175627
• MDR Text Key: 195945230
• Report Number: 10175627
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/08/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 71