MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE

Model Number 80040

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Initially, it has been requested by the customer to swap out one of the rotoprone bed due to a "communication error".It is unk to what this claimed "communication error" was related or how long it was present.Additionally provided info revealed that the device failed while being in use - when the device was rotated into the prone position.Due to the failure it was not possible to rotate the pt electrically any more.Nevertheless, despite of our best effort, we were unable to define the exact circumstances under which the event occurred.Reference mfr report number: 3009988881-2015-00012.

• Brand Name: ROTOPRONE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 4591213
• MDR Text Key: 5481627
• Report Number: 1419652-2015-00081
• Device Sequence Number: 1
• Product Code: IKZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 80040
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other