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

Model Number 209500

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Material Too Soft/Flexible (4007)

Patient Problem Pressure Sores (2326)

Event Date 04/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

Arjo was notified on (b)(6) 2019 that a female patient sustained pressure injuries while on the rotoprone system.It was reported by the customer that the patient had skin assessed on (b)(6) 2019 (it could not been done earlier due to long prone times) and found a stage 1 pressure injury on the right heel, slight and minor deep tissue injury under right eye.The customer inspected the bed and found that on the right foot board there was less padding that on the left one.Also less padding was noticed on the interior right side "rail".Deep tissue injury was further described as, "overall looks pretty good," and, "it should resolve in a day or two".

Manufacturer Narrative

On 28 may 2019 the rotoprone bed was set for repair, where, among other bed components, foot pad was replaced.Additional information will be provided when the investigation conclusion is available.

Manufacturer Narrative

Arjo was notified that a female patient sustained pressure injuries while on the rotoprone system.It was reported by the customer that when the patient had skin assessed it was found slight and minor deep tissue injury under right eye and a stage 1 pressure injury on the right heel.The customer stated that the skin assessment could not have been done earlier due too long prone time.Deep tissue injury was further described as, "overall looks pretty good," and, "it should resolve in a day or two".The customer inspected the bed and found that on the right foot board had less padding that on the left one.Also less padding was noticed on the interior right side "rail" (support pack).The nurse stated that, "it seems to stop almost mid foot".In order to respond to those allegations, service history of this device was reviewed.It showed no previous records related to foot pad, face pack or side packs replacement.The last quality process was performed on 4 apr 2019, no parts were replaced or repaired.The bed was functioning correctly.Part of the quality process is to clean all packs and pads and check the foam.The face pack is replaced every 72 hours or if needed.In case the service technician noticed the failure during quality control process, the bed is repaired and faulty components replaced.Only fully functional devices are delivered to the customer.In the course of the investigation we have not found a correlation between deep tissue injury under right eye or stage 1 of pressure injury on the right heel.The face pack components were in good condition, no damages were detected.There are numerous factors which may influence the injury such as, different adjustment of the left foot pad in comparison to the right foot, patient positioning, face pack adjustment, patient medical condition and necessity to keep the patient in prone position for prolonged time.The rotoprone therapy system is prescribed for patients suffering from the consequences of immobility, the system is to help caregivers address potentially life-threatening conditions by means of prone therapy, but proning itself may present risk of pressure injury.Product user manual includes steps that can be considered while managing potential skin complications.User manual warns: - "fitting the head support, face pack or other packs too tightly may increase pressure points, possibly leading to skin breakdown.Assess skin at frequent intervals depending on patient condition (at least every four hours).Give extra attention to skin at pressure points and locations where moisture or incontinence my occur or collect.Common pressure points include, but are not limited to, the face, ears, axilla, shoulders, sides and upper and lower extremities.Early intervention may be critical to preventing serious skin breakdown.Do not leave patient in a stationary position in the supine or prone position for more then two hours".- "friction on the feet can also contribute to skin breakdown.Consider these precautions: when supine, elevate heels off of therapy surface.Continue using sequential compression devices (scds) during prone therapy if ordered by treating physician.".The rotoprone bed is equipped with an alarm, which is triggered in case patient has been in prone position more than 3 hours and 15 minutes in order to remind caregivers about skin assessment.Another alarm is triggered when the bed surface has been in stationary position for more than 30 minutes.Risk benefits analysis for rotoprone indicates that patients in critical care units are at significant risk of skin breakdown related to physiological decompensation as well as prolonged static positioning.There is increased risk of skin breakdown in patients placed in the prone position versus patient in the supine position and thus this risk is well-known and understood in the medical community caring for these patients.There are various methods to manage pressure ulcer and therefore the risks of skin breakdown are usually deemed less than the risk of significant physiological decompensation the patient may experience.The understanding of risks associated with prone therapy is important, and is clearly discussed in rotoprone product labeling.In general these risks are acceptable relative to the risk of death associated with refractory hypoxemia.In practice, the treating physician assesses these risks in the context of the potential benefit of the therapy to the individual patient upon prescribing the therapy.When reviewing reportable complaints about rotoprone and skin injuries sustained, we have found 20 complaints (searched from april 2014 till june 2019), there have been 20.485 orders, which gives occurrence rate of 0.098%.The probability of occurrence of harm is rare, the overall risk is acceptable.In summary, proning itself presents risk of pressure injuries and it is possible that the pressure injuries were related to patient medical condition and not issue with packs.The customer stated that the patient skin could not have been assessed earlier because of too long prone time, this would confirm that the injuries were related rather to patient's medical condition and necessity to keep the patient in prone position for longer time rather than any product issue.The device was used for patient treatment when the event occurred, therefore played role in the event, however no failure that would cause the injuries was found.The device performed as intended, the proning itself may present inherent risk of serious injury.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 8590589
• MDR Text Key: 144405306
• Report Number: 9681684-2019-00045
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization