MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. ROTOPRONE; BED, PATIENT ROTATION, POWERED

Device Problems Mechanical Problem (1384); Self-Activation or Keying (1557)

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

Event Date 01/04/2019

Event Type  malfunction  

Event Description

Recently placed pt in rotoprone bed at 0435.Began proning pt at 0455.Checked red manual rotation latch and bed brakes before rotation began.Pt was tolerating bed well on rotation.At approx.0615, rn was standing at the head of the bed when suddenly the red manual rotation latch flung open and patient's bed quickly began to rotate manually on its own.Rn quickly grabbed the bed along with team lead and fellow rn who happened to be standing in the doorway of the room.Bed was manually brought back to zero degrees and lock pin was pulled.Rn zip-tied the red manual rotation latch shut, and notified manufacturer rep of bed malfunction and to order a new bed immediately.Nurse manager notified.Rn spoke with manufacturer rep, customer service reps and ordered a new rotoprone bed to be brought to the patient's room immediately.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; 12625 wetmore road; suite 308; san antonio TX 78247
• MDR Report Key: 8639729
• MDR Text Key: 146048497
• Report Number: 8639729
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2019,02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Weight: 86