MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOPRONE; BED, PATIENT ROTATION, POWERED

Model Number 209800-R

Device Problems Difficult To Position (1467); Device Operates Differently Than Expected (2913)

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

Event Date 02/20/2017

Event Type  malfunction  

Event Description

Patient on bed in supine position.Bed stuck in rotated position to the right.Representative called and unable to troubleshoot over the phone.Patient was calm and stable.Manufacturer response for rotoprone bed, rotoprone bed (per site reporter).Attempt to troubleshoot over the phone unsuccessful.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 2349, w lake street - suite 250; addison IL 60101
• MDR Report Key: 6521842
• MDR Text Key: 73695656
• Report Number: 6521842
• 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: Other
• Type of Report: Initial
• Report Date: 04/17/2017

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: No Information
• Device Model Number: 209800-R
• Device Lot Number: 3000084079
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Age: 73 YR