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

Device Problem Unclear Information (4052)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

(b)(4).It was reported to arjo representative during gathering additional information to another complaint (b)(4) originated by the same (b)(6) medical center customer facility (reported under manufacturer 9681684-2019-00004), that the several patients during therapy on the rotoprone bed sustained deep tissue injuries on the knees and foreheads.No additional information have been provided related to event circumstances and how many patients sustained injuries.The rotoprone is indicated for the treatment and prevention of pulmonary complications of immobility.Rotoprone user manual (ifu) 208662-ah rev.D contains consideration for skin care.There are described ways to minimize skin breakdown as per ifu: "assess skin at frequent intervals depending on patient condition (at least once every four hours)"."do not leave patient in a stationary position in the supine or prone position for more than two hours"."early intervention may be essential to preventing serious skin breakdown", "prolonged static positioning may increase risk of skin breakdown" moreover the ifu contains information that "proning itself may present inherent risk of serious injury", such as skin breakdown.In case bed is in prone position for more than 3 hours and 15 minutes, the alarm will be activated to warn that maximum recommended prone time was exceeded.As per ifu corrective action involves "return patient to supine position to assess the skin at frequent intervals.If patient remains in prone position in excess of this time, patient may be at risk of skin breakdown or other complications.Always follow physicians orders for prone time." the above constitute only recommendations and will not replace a clinician assessment.The therapy depends on patient 's medical condition.Please note, that the bed is used to help address potentially life-threatening conditions however, the proning itself may present risk of serious injury such as skin breakdown.The bed is not intended to prevent skin breakdown but to treat complication associated with immobility.To sum up, the rotoprone therapy system was used for patient treatment at the time of event and thus played a role in the incident.Due to fact that the system was not identified and limited information was provided to complain the root cause cannot be defined with certainty.We report this incident because of an allegation of serious injury and limited information received.

Event Description

It was reported to arjo representative during gathering additional information to another complaint (b)(4) originated by the same (b)(6) medical center customer facility (reported under manufacturer 9681684-2019-00004), that the several patients during therapy on the rotoprone bed sustained deep tissue injuries on the knees and foreheads.No additional information have been provided related to event circumstances and how many patients sustained injuries.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 8369267
• MDR Text Key: 137132338
• Report Number: 9681684-2019-00017
• 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: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention