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

Model Number 209500

Device Problems Use of Device Problem (1670); Human Factors Issue (2948); Adverse Event Without Identified Device or Use Problem (2993)

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

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 (b)(4).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under (b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under (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 rotoprone bed.The device is part of the arjohuntleigh us rental fleet and has been rented to customer: st joseph's hospital and medical center.The complaint was that the patient developed bilateral deep tissue injuries on chest after 11 hour proning.During bed inspection at a facility site, it was found that the patient had wider body type, the side support pack was placed between second and middle post and that the side support was not extended.Additional information provided was that patient's medical health condition requires keeping the patient in prone position for 11 hours, without possibility to return to supine for skin assessment.Side support can be adjusted as needed to accommodate patient size.In order to do so side support packs may be placed in tapered in position (for narrow body type, pack with blue knob is placed on patient's left side and pack with green knob is placed on patient right side) or tapered out position (for wide body type, pack with green knob is placed on patient's left side and pack with blue knob is placed on patient right side).Also, the bed is equipped with three posts, located on right and left side of the bed, where side support packs are placed in.Depending on the body type, end of side support packs can be placed in between outside and middle support posts or in between inside and middle support posts (for wider body type).In addition the patient surface can be adjusted with use of adjuster crank to position side packs snugly against patient's sides.This prevents patient from sliding side to side when rotated.User manual 208662-ah rev.D dated on may 2016 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.The document warns to "assess skin at frequent intervals depending on patient condition (at least once every four hours).Give extra attention to skin at pressure points and locations where moisture or incontinence may occur or collect".It is recommended to not leave patient in a stationary position in the supine or prone position for more than two hours.As stated in user manual "early intervention may be critical to preventing serious skin breakdown".The document warns also to "check patient at regular intervals to ensure patient has not migrated downward in the unit and come in contact with any hard surface" as this may result in skin breakdown.From the above it seems that the way the packs were placed indicates a narrow body type, also not extended side packs, suggests that a patient was placed on the rotoprone too tightly, which may result in increased pressure points during therapy.Also, inability to divide the therapy into prone and supine intervals might increase risk of skin breakdown.The asset serial no (b)(4) was pre-placement inspected in accordance to quality control check and passed the manufacturer's requirements.After it returned from rental, it was tested per quality control procedures post placement: the bed passed qc checks, functioned as designed and met specifications.No anomalous conditions were found on the bed.No repair were required, which would mean that there was no bed malfunction.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.There is no complaint trend observed for this failure mode and occurrence is considered to be remote.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.Taking the above into consideration, it can be deemed that few factors contributed to the incident: patient medical health condition precluded from therapy division into intervals, which would minimize a skin breakdown, user's technics used for patient placement and positioning within the unit.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, the device met manufacturer's specification.We report this complaint due to patient outcome - bilateral deep tissue injury on chest.This injury required medical intervention to prevent permanent impairment, therefore it was deemed reportable since it met the definition of serious injury.

Event Description

Arjohuntleigh received a complaint which stated that a patient sustained deep tissue injuries after 11 hours in prone position.First tissue injury was located on right, lateral, medial chest/torso of patient (size: 4.5cm length x 5cm width); second on left, lateral, medial chest/torso of patient (size: 4cm length x 4 cm width).Additional information provided was that patient's medical health condition requires keeping the patient in prone position for 11 hours, without possibility to return to supine for skin assessment.

• 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 ; 698282467
• MDR Report Key: 6621261
• MDR Text Key: 76948870
• Report Number: 3007420694-2017-00140
• 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: 06/08/2017

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: 05/17/2017
• Initial Date FDA Received: 06/08/2017
• 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