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

Device Problems Cut In Material (2454); Difficult to Open or Close (2921); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2016

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 limited number of similar complaints in the past, which relates to buckle being unable to open.There is no trend observed for this failure mode.The product involved in the incident is rotoprone bed serial number: (b)(4).The device is part of the arjohuntleigh us rental fleet and has been rented to the customer (b)(6).Before the product was released to the customer, the bed was inspected per quality control checklist and no deficiency was found.During the use of this device, the customer raised an allegation that the buckle cannot be unlocked.Arjohuntleigh representative was dispatched to the facility to appraise the situation and assist in solving the reported issue.Upon the inspection, the technician did not found technical failure within the buckle.He observed that buckle strap was pulled too tightly which made it difficult to open.As a solution, the strap needed to be cut to access the patient.When the strap was cut the tension was released from the buckle assembly and it could be confirmed that the buckle operated as intended.After the bed was returned from rental, it was checked again per quality control checklist and no failure was found.As per user manual (208662-ah rev.D), tightness of pack straps varies 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".The document presents using graphics the way how to open the buckle and how to tighten the straps.Buckle opens when the release button is pressed down, which releases two sides of the strap.In order to tighten the proning packs, the packs needs to be first pushed downward with one hand then the strap needs to be tighten with other hand.If the patient is packed in too tightly, the button on the buckle does require more force to release.An arjohuntleigh representative who visited the facility stated that the strap was pulled very tightly.This caused that more pressure was put on the buckle release, which made it hard to operate.There was no product malfunction, after the strap was removed from the device, the buckle was verified as operated properly.The buckles function as a car seat belt buckles.When pressing down on the center release button, it is sometimes necessary to push down on the patient pack to minimize the tension of the strap and allow enough slack for the buckle to release two sides of the strap.In summary, the rotoprone device was used for patient treatment at the time of event occurrence and thus played a role in the incident.However, it was deemed that there was no product malfunction.The event was related to the buckle strap tightening which made impossible for the release button on the buckle to open and in a consequence the strap was cut.Although, no injury sustained as a result of this event it was decided to report it to the competent authorities in abundance of caution based on the potential for serious injury.The customer was educated by an arjohuntleigh representative how to properly tighten the buckle strap and how to open the buckle, therefore 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

Arjohuntleigh received a complaint from the customer that the pelvic buckle became stuck and could not be released.An arjohuntleigh representative who went to the facility to help resolve the issue informed that the buckle strap was pulled very tightly.The attempt to release tension on the buckle was not effective and eventually the buckle strap was cut.The damaged buckle strap was replaced on site.An arjohuntleigh representative stated also that the buckle worked as intended after removed from the device when the tension was released.The staff was educated on proper tightening and releasing buckle strap.It is worth mentioning that the patient condition was stable, there was no injury in relation to this event.

• 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: 6492875
• MDR Text Key: 72884726
• Report Number: 3007420694-2017-00084
• 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
• Type of Report: Initial
• Report Date: 04/14/2017

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/17/2016
• Initial Date FDA Received: 04/14/2017
• 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 Weight: 86