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

Model Number 209500

Device Problems Device Issue (2379); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2017

Event Type  malfunction  

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 registration #(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 registration #(b)(4).When reviewing reportable events for rotoprone device we were able to establish that there have been similar complaints in the past.There is no trend observed for this failure mode however.The product involved in the incident is a rotoprone.The device is part of the arjohuntleigh us rental fleet.The device was rented to the customer (b)(6).Buckles are used to restrain a patient on the rotoprone when the patient is in supine and prone therapy.The buckle assembly functions much like a seat belt buckle with webbing connected on the right and left side of the bed and a tongue and buckle that get latched in the center of the bed to restrain the patient.The operator of the device is to click together the male and female end of the buckle and tighten the pack straps.Tightness of pack straps will vary according to each patient's needs.Straps need to be as tight as can be tolerated, as patient will shift into the prone packs and away from the patient surface when moved into prone position.Buckle is released by pressing the button inside the buckle.In the complaint the allegation was that the button on the buckle could not snap back, when pressed it stayed down.This resulted in inability to open a buckle.The buckle plastic cover was stripped by an arjohuntleigh technician, which allowed to reach to the buckle release mechanism.Using a screwdriver the mechanism was pressed and the buckle released.The buckle required replacement.User manual (#208662-ah rev.D), which is provided along with each device, contains all crucial warnings, cautions and instruction which should be followed to ensure the patient safety.In the document following information can be found: - the instruction how the buckle should be fasten and unfasten, - requirements of daily equipment instruction (including checking the appearance and functionality of the buckle).The device inspection was performed prior to rent in accordance to quality control (qc) checklist on 4th may 2017 and no anomalies were recorded, all bed functions operated correctly.On 13th may 2017 arjohuntleigh was informed about the issues with the buckle release mechanism.It is unknown why the release mechanism failed in a way that the buckle could not be opened.There may be several factors which might contributed to it: strap was fasted too tightly and in attempt to open the buckle it was damaged, female and male component was connected incorrectly, a buckle release mechanism was tackled by an obstruction ( e.G.A piece of clothes, dirt).In summary, the arjohuntleigh device played a role in the event as it was used for the patient treatment upon the occurrence.The device failed to meet its specification.Although this event did not result in an injury, it has been decided to report it to the competent authorities based on the potential and in abundance of caution.Given the circumstances and the fact that there is no trend observed for this failure mode arjohuntleigh does not propose any other action at this time.

Event Description

An arjohuntleigh was reported by the customer that they have difficulties in opening chest buckle.A nurse stated that when they pressed the button on the buckle, it stayed down, which make impossible to release the buckle.There was no injury to a patient in relation to this event.A service technician who went to the facility to resolve the situation, reported that an attempt to relieve tension on the buckle did not work.The technician needed to dismantled the plastic cover from the back side of the buckle to reach to the release mechanism.With use of screwdriver the mechanism was depressed.The faulty buckle was replaced.The technician then checked the remaining buckles and confirmed that they were in perfect working condition.The therapy was continued.

• 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: 6617219
• MDR Text Key: 76837387
• Report Number: 3007420694-2017-00138
• 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: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/13/2017
• Initial Date FDA Received: 06/07/2017
• 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