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

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem Cardiac Arrest (1762)

Event Date 01/28/2015

Event Type  Injury  

Event Description

Rotoprone therapy system (bed) locked into position during manual rotation of patient.The touch screen froze and was unresponsive.Patient stuck on side and then coded.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore rd ste 308; san antonio TX 78247
• MDR Report Key: 4544314
• MDR Text Key: 5506538
• Report Number: 4544314
• 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: 02/06/2015

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?: No
• Device Operator: Nurse
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR