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

Model Number 209500

Device Problems Mechanical Problem (1384); Device Issue (2379); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation has been performed and the conclusions are as followed: the product involved in the incident is a rotoprone therapy system, which is part of the arjohuntleigh us rental fleet and was rented to customer providence healthcare network.When reviewing reportable events for rotoprone we have not found other complaint which would concern situation in which both automatic and manual rotation do not work due to mechanical failure and bed cannot be moved from prone to supine position while patient is on the device.There is no trend observed for the investigated issue.The complaint was that the nursing staff was unable to place the patient surface from prone back to supine, regardless of multiple attempts made.The patient remained on the bed untill the service consultant went to the customer to resolve the issue.When an arjohuntleigh representative removed the foot end plastic cover found that roller assembly was damaged, the patient surface had shifted to the foot end of the device, which resulted in toggle pin being stuck in the solenoid assembly (solenoid support weldment opening for solenoid stop arm weldment).This in result did not allow automatic and manual rotation of the device.With use of the crowbar the bed surface could be moved up, which allowed the clearance alignment for the toggle pin to move freely.The bed then could have been rotated to supine using emergency release procedure.The patient was transferred to another rotoprone.There is no indication of an injury in relation to this incident.The asset was returned to the service center for repair.The rollers at the foot end were replaced, during cleaning process it was found that the midline hatch was damage.The hatch failure, however, is not related to the reported issue.After roller replacement the bed rotated as intended.The bed has 4 ultra high molecular weight (uhmw) rollers with sealed bearings that rotate on pins located at each corner of the u frame on the head end and foot end of the bed.Patient left foot end roller is unique in that it is shimmed to limit head to foot displacement of the patient frame.Rollers allow the patient frame to rotate.On rollers is placed halo (a wheel shape part), which allows smooth motion of rotating frame.The asset had rollers checked during annual inspection in accordance to work instruction which was completed on 28 july 2016 and not fault or excess wear was identified.Also no defects were noticed during pre-placement quality control check (qc) and cleaning procedure which was completed on 1st september 2016.It is unknown why roller assembly failed and in a result patient surface could not have been placed back to supine.It is, however, possible to list few likely root causes of the issue: parts could wear and tear due to its lifecycle e.G.: constant bed rotation and therefore movement of halo on the rollers may lead to its worn over time; damage can be a result of transport/shipment errors e.G.Incorrect protection of the device may lead to excessive movements and bed my suffer from external damage due to hitting walls or other elements.No complaints were found concerning the same or similar sequence of events in arjohuntleigh complaint handling system, and from that perspective this particular complaint is considered an isolated occurance.In summary, the device was being used for treatment at the time of the event and therefore was directly involved in the event.The device failed to meet manufacturer's specification.Failure of rollers on its own does not cause or contribute to death or serious injury.The device is an acute care bed that would necessitate patients being very closely monitored, depending on their diagnosis or condition.As a safety precaution, if a failure of inability to prone the patient occurs, the patient can be put to prone through conventional means either by manually rotating the patient on the rotoprone surface or moving to another surface for manual proning.The potential for serious injury may occur in the situation when the patient is placed in prone position and rollers failed to the extent that the bed surface lost its intended position, which precludes the patient surface from being placed back into supine both via computer and using manual rotation feature to take the patient off of the device.Therefore, although there was no injury reported in relation to this even, taking the above into consideration we decided to report this event in abundance of caution as in case of emergency this type of failure (inability to use rotation functions to turn the bed to supine) may result in harm of high severity.Given the circumstances and that this event is an isolated one, arjohuntleigh do not propose any further action at this time, but will continue to monitor for any further events of this nature.

Event Description

An arjohuntleigh representative received a call from the nurse which informed that the rotoprone device got stuck in prone position and the nursing staff was unable to return it back to supine position.It was stated by the call operator that all attempts to turn the device, including using emergency release lever, resetting the bed, pulling and pushing out lock pin, failed.The bed was making grinding noise and would not move more than a few degrees to either side.The issue was escalated to the technician who was not able to correct the situation, therefore a service center was called to replace the bed.An arjohuntleigh representative who went to the customer to resolve the issue, found that roller assembly was damaged, the patient surface had shifted to the foot end of the device, which resulted in toggle pin being stuck in the solenoid support weldment opening for solenoid stop arm weldment.This in result did not allow automatic and manual rotation.With use of the crowbar the bed surface could be moved up, which allowed the clearance for the toggle pin to move freely.The bed then could have been rotated to supine using emergency release procedure.The patient was transferred to another rotoprone.There is no indication of an injury in relation to this incident.

• 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: 6559650
• MDR Text Key: 75210158
• Report Number: 3007420694-2017-00109
• 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: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2016
• 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