MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOREST; BED

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

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

Event Date 01/31/2015

Event Type  No Answer Provided  

Event Description

A patient with an unstable spine fracture was to be placed on a rotorest bed while in the emergency department.The rotorest bed was ordered from the vendor and was delivered to the critical care unit by the vendor a few hours later.The agent who responded to the request reported that he could only deliver and zero out the bed and that there was no representative available to set up the bed.(the rotorest bed is to be set-up by a qualified representative from the vendor.) after consulting with the physician and nursing leadership, it was determined that the patient needed to be placed on the rotorest bed.The critical care unit nurses were able to get the rotorest bed set-up and the patient was transferred safely into the rotorest bed.Functionality issue (same patient/same rotorest bed).The next morning, there was a loud "clunking" sound when the patient was turned 40 degrees for hatch cares.The lower left panel (containing the lowest hatch) had a disengaged pin, and it came undone from the side of the rotorest frame.The bed rotated slowly and carefully to right side and was able to re-engage panel.Three people were required to replace the panel with the patient in the bed.Later that same day, there was a loud "clunk" when the patient was turned 40 degrees to the left to do hatch cares.The lower left panel (not hatch) of bed had a disengaged pin holding the panel to the frame.Again, it took three staff to get the issue fixed.The rotorest representative was contacted via a phone call and there were no additional rotorest beds available.Instructed not to turn the patient greater than 20 degrees.The patient was scheduled for surgery early the next morning and the rotorest bed was discontinued after surgery.

• Brand Name: ROTOREST
• Type of Device: BED
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 2349 w. lake street; addison IL 60101
• MDR Report Key: 4549037
• MDR Text Key: 5527136
• Report Number: 4549037
• Device Sequence Number: 1
• Product Code: IKZ
• 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: 02/24/2015

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?: *
• Device Operator: Nurse
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR