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

Model Number 209800-R

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

Patient Problem Skin Tears (2516)

Event Date 08/19/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient was placed in rotoprone bed by nursing staff on (b)(6) 2017 and turned to prone position for 16 hours.When patient was returned to supine position and proning packs unpacked the rn noted in her chart the skin injuries on the chest and abdomen.Injuries were located specific to the region of abdominal sling placement.

Manufacturer Narrative

An investigation was performed into the issue and conclusions are following: the rotoprone bed is intended to provide kinetic therapy (lateral rotation up to 62 degrees) and proning therapy with simultaneous 62 degrees lateral rotation while in prone positioning.The rotoprone is indicated for the treatment and prevention of pulmonary complications of immobility.The device involved in the incident is rotoprone bed.The device is part of the arjohuntleigh us rental fleet and has been rented to customer: mayo clinic health system eau clair.The event scenario of the reported incident was following: the patient was placed on rotoprone system on (b)(6) 2017 and placed in prone position.He remained in that position for the next 16 hours.When the patient condition improved a nurse decided to turn the patient to supine position.The proning packs were removed and skin blisters in chest and abdomen region were noticed.It was stated that the injuries were located specifically to the region of abdominal proning pack placement.As a treatment non-adhering dressing and lite foam dressing was applied.The nurse stated that "she packed patient in bed correctly".This facility had last cope training on (b)(6) 2016.The asset serial no (b)(4) was inspected on few occasions after the event ((b)(6) 2017) in accordance to quality control check and passed the manufacturer's requirements.No anomalous conditions were found on the bed.No repairs were required, which would mean that there was no bed malfunction.For this reason another factors that possibly may lead to skin breakdown while on the rotoprone therapy system were taken into account: prolonged static positioning.Packs placement not in accordance to patient body type, which may increase pressure points.Side packs not tight enough, which may result in patient migration during therapy and scrape hazard.Patient medical condition does not allow earlier assessment of the skin condition.As per user manual (ifu) (b)(4): "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"."packs may also be switched from side-to-side to accommodate narrow or wide body type" "snugness of the side packs will vary according to each patient's needs.Side packs need to be as tight as can be tolerated, as patient will shift slightly when rotated." in the investigated scenario according to information received from the customer, the patient was packed properly, was placed in prone position for 16 hours, and that the injuries were located specifically to the region of abdominal proning pack placement.Looking at the investigation analysis, it can be stated that few main factors contributed to the incident, prolong static positioning, patient body type and patient 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.Review of similar reportable events, revealed that there have been reportable complaints in the past, which cover problem with patient sustaining pressure ulcer during therapy.There is no complaint trend observed for this failure mode and occurrence rate is considered to be low.Taking the above into consideration, it can be deemed that the incident was related to the patient medical condition and not failure of the device.To sum up, the rotoprone therapy system was used for patient treatment at the time of event occurrence and thus played a role in the incident.However no failure was found during quality control inspection, the device met performance specification.We report this complaint due to the number of injuries as well as the patient's compromised condition.

• 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 ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL
• MDR Report Key: 6867870
• MDR Text Key: 86263643
• Report Number: 3007420694-2017-00193
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209800-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2017
• 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): Hospitalization
• Patient Age: 48 YR
• Patient Weight: 122