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

Model Number 209500

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

Patient Problem Tissue Damage (2104)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).An investigation was performed into the issue and conclusions are following: the rotoprone therapy system is a patient care system for the prevention and treatment of complications associated with immobility.The bed is intended to provide kinetic therapy (lateral rotation up to 62 degree) and proning therapy (simultaneous 62 degree lateral rotational while in prone positioning).The device involved in the incident is a part of the arjohuntleigh us rental fleet and had been rented to customer (b)(6) medical center.A customer called to express a concern about a patient which developed significant breakdown on the face, shoulders, anterior chest, knees, shins and toes.The customer requested for arjohuntleigh representative help to reduce wound incidents as they have experienced similar issues with other patients.The stage of skin breakdown was not provided by the customer.Upon the nursing staff request for the additional guidance in regards to skin care, an arjohuntleigh clinical educator provided the guidelines information and indicated an importance of avoiding stationary positioning and to make sure the device was placed in reverse trendelenburg while rotating.According to device user manual 208662-ah rev.D "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 once every four hours).Give extra attention to skin at pressure points and location where moisture or incontinence may occur or collect.Common pressure points include, but are not limited to, the face, axilla, shoulders, sides and upper and lower extremities.Early intervention may be critical to preventing serious skin breakdown".It is recommended to not leave patient in a stationary position in the supine or prone position for more than two hours.The documents indicates steps that should be considered to help manage potential skin complication that can be associated with prone therapy e.G.Face pack shall be removed at regular intervals to assess skin, when in prone it is recommended to open back hatches to minimize skin breakdown to shoulders, when is supine it shall be considered to elevate heels off of therapy surface.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 (possible side effects).The bed is not intended to prevent skin breakdown but to treat complication associated with immobility.Before the asset was released to next rent it was checked in accordance to quality control check (qc).After it was returned from rental, it was tested again per quality control procedures post placement: on both occasions, the bed passed quality control (qc) checks, functioned as designed and met specifications.No anomalous conditions were found on the bed.Review of similar reportable events, revealed that there have been similar complaints in the past, which cover problem with patient sustaining pressure ulcer during therapy, however there is no complaint trend observed for this failure mode and occurrence is considered to be remote.In the course of the investigation, it was assessed that the incident was related to the user way of handling the device (leaving patient in stationary position for prolonged time), patient positioning within the unit (incorrect position, insufficient tightness of proning packs may lead to patient excessive movement within the device during rotation and skin scrape) or insufficient patient skin care during therapy.The rotoprone device 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 and from that perspective we may assume that at the time of the issue the device met the manufacturer's specification.A patient developed significant skin breakdown, but limited information provided has not allowed us to make an accurate assessment of the patient's injuries, therefore we report this incident in abundance of caution since a serious injury cannot be excluded.

Event Description

A customer called to express a concern about a patient which developed significant breakdown on the face, shoulders, anterior chest, knees, shins and toes.The customer requested for arjohuntleigh representative to help reduce wound incidents.The facility was both called and visited in person to provide guidelines in regards of skin care.No information regarding stage of skin breakdown and patient weight was provided.

• 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 ; 98282467
• MDR Report Key: 6526652
• MDR Text Key: 73901715
• Report Number: 3007420694-2017-00102
• 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
• Report Date: 04/27/2017

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
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 04/27/2017
• 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