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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); Pressure Sores (2326)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetic concept inc (under registration #1625774).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration #3009988881.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4)'s complaint handling establishment and any medwatch reports will be submitted under registration #307420694.An investigation was performed into the issue and conclusions are following: the allegation was that the patient developed bilateral facial deep tissue injury and deep tissue injury on right great toe.The patient was placed on the rotoprone therapy system from january 24th till january 31st.On (b)(6), the patient was noticed to migrate down, therefore the face pack and lower prone pack were corrected.6 days later a breakdown on the patient's face was noticed.The patient was very prone dependent therefore closer examination at that point was impossible.When the patient was taken off of the rotoprone on (b)(6), deep tissue injury was discovered on both side of the face and right great toe.The therapy discontinued because the patient's condition improved and was stable enough to came off of the bed.The device involved in the incident is the rotoprone bed, which is a part of the arjohuntleigh us rental fleet and had been rented to customer: the toledo hospital.After the unit was returned from rental, it was tested per quality control procedures post placement: the outcome is the same as that of the pre placement qc: on both occasions, the bed passed quality control (qc) checks, functioned as designed and met specifications.No anomalous conditions were found on the bed.When reviewing similar reportable events, we were able to establish that there have been similar complaints in the past, which cover problem with patient sustaining injuries during therapy.There is no complaint trend observed for this failure mode and occurrence is considered to be remote.The device's user manual states that the head support, face pack and other proning accessories shall not be fitted too tightly as this may increase pressure point and result in serious skin breakdown.Patient skin is to be assessed at frequent intervals depending on patient condition (at least once every four hours).Face pack shall be removed regularly to assess the facial skin.It is recommended to not leave patient in a stationary position in the supine or prone position for more than two hours.If patient remains in prone position for excess time, it is recommended to returned to supine position to assess the skin as prolong proning may pose risk of a skin breakdown.User manual provides, also, guidance of how to place and adjust face pack assembly and install lower leg proning packs, it states: "assess position of cheek packs on patient's cheeks and chin.[.] face pack should rest lightly on patient's forehead, cheeks and chin with no compression of the foam", "avoid applying pressure to patient's feet, toes, knees or top of foot.Shorter patient may not require lower leg packs for support".The documents provide illustration how to place lower leg proning in case of shorter patient or if a patient is taller.It states to not cover knees or toes with proning pack as they should be visible.The bed was checked after the event and no deficiencies were noticed.Also, the nursing staff seems to act appropriately to the situation.Whenever it was possible patient position and proning packs were corrected per user manual.The patient was very prone dependent, therefore placing in the supine position might have not been beneficial to the patient's recovery.When such situation occurs, the effort are made to minimize the need for supine positioning for routine care or to minimize the amount of time required for intervention or care due to the severe patient condition.Clinicians and caregivers aware of the situation evaluate how to perform intervention in such cases.In this complaint it was decided to continue the prone therapy for the patient's benefit.On (b)(6), patient's condition improved and therapy could have been discontinued.Taking the above into consideration, it was deemed that the actual root cause of the incident cannot be defined, there was no product defect, a caregiver was aware how to operate the device and acted accordingly to the situation and for patient's benefit.The rotoprone device was used for patient treatment at the time of event occurrence and thus played a role in the incident.However after the comprehensive evaluation, it was found that the bed did not fail to meet the manufacturer's specification.The patient did sustain a serious injury, thus the event was decided to be reportable to competent authorities as such type.

Event Description

A patient was placed on the rotoprone therapy system on (b)(6) 2017.During a round on (b)(6), patient was found migrated down, hollister et was in place, face pack tight, lower prone pack covered toes.At first available opportunity patient was repositioned: face pack corrected, prone pack relocated of the feet.On (b)(6), it was noticed that patient was in a better position: face pack not so tight in comparison to previous placement, hollister was in place, foot pad was not covering toes.On (b)(6), it was indicated that the patient had breakdown on face.Patient was very prone dependent and the closer visualization was impossible.When patient was taken off the rotoprone on (b)(6), deep tissue injury was discovered on both side of the face and right great toe.The therapy discontinued because the patient's condition improved and was stable enough to came off of the bed.The facility underwent multiple training courses.For the new critical care nurses, the course was provided on (b)(6) 2017.

• 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: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6375681
• MDR Text Key: 68972919
• Report Number: 3007420694-2017-00047
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2017

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 50 YR
• Patient Weight: 106