MAUDE Adverse Event Report: ARJOHUNTLEIGH AB ROTOPRONE THERAPY SYSTEM; BED, PATIENT ROTATION, POWERED

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Pressure Sores (2326)

Event Date 07/03/2019

Event Type  malfunction  

Event Description

Physician ordered patient to be placed in rotoprone bed on [date redacted].Patient with persistent marginal oxygenation despite f102 0.9 to 1.0, peep 16 and flolan.Preventative mepilex dressings were placed prior to proning the patient.Wound ostomy care (woc) nurse assessment that patient's risk factors include: elderly, immobility, incontinence, morbid obesity, persistent malnutrition and protein loss, decreased level of consciousness (loc) and inability to participate in own care, receiving mechanical ventilation, sepsis and prolonged prone position.Despite pressure ulcer prevention interventions including adjusting leg pads to off load hips, applying extra foam padding, spacing at hips for repacking, by two days later, the woc rn assessed deep tissue pressure injuries on the patient's bilateral hips.The pressure that caused the injuries to the bilateral hips is believed to be from the leg pads which are required to pack the patient in the rotoprone bed.The long leg pad has the ability to be in two different slots.The inner slot was selected, and this put pressure on the hips and from cranking the bed (bed slides in to fit the patient and create a snug fit.) also, there are pressure points from the design of the bed (i.E.Metal bars under compressed pads).Nursing team members have expressed that when we have a prone patient in the rotoprone bed, there is the opportunity for a new location of pressure injury to occur.It seems that even when the rep is present during the initial proning to assist with packing, etc., we are still seeing pressure injuries develop.Cranks are hard to turn, the cushions are hard, the leg pad and slots do not always fit every patient.It is hard to accommodate the rotoprone for each individualized patient need.

• Brand Name: ROTOPRONE THERAPY SYSTEM
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH AB; 12625 wetmore road; suite 308; san antonio TX 78247
• MDR Report Key: 8830738
• MDR Text Key: 152388894
• Report Number: 8830738
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/16/2019,07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28470 DA
• Patient Weight: 128