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

Model Number 209500

Device Problems Break (1069); Crack (1135); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2018

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 kinetic concept inc (under registration #1625774).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration #3009988881.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #307420694.Additional information will be provided upon conclusion of the investigation.

Event Description

As reported by the customer, middle hatch could not be closed because hatch hinge broke and the hatch shifted.The patient remained in the prone position until arjo field technician arrived to the customer to assist in patient placement to supine position.

Manufacturer Narrative

The investigation was performed and the conclusions are following: a customer reported that hinge located on the middle hatch of rotoprone therapy system and would not lock.It was stated that when the customer staff was trying to close and secure the middle hatch, they noted that the hatch did not lock into place.A right side of the hatch had separated from the hinge and in a result the whole hatch dislodged and was not operable any longer.The malfunction was detected at the time the patient was in prone positon and could not be turned into supine due to safety reasons (it was still possible to use manual rotation, but an individual did not want to turn the surface to supine position as an open hatch created a gap through which a patient could exit the bed unintentionally).Customer concern was that in case of emergency situation, the bed could not be placed to supine position.The patient remained in prone position until an arjohuntleigh repair technician arrived to the facility and helped placing the bed into supine using manual rotation feature and by blocking the sensor (it senses open hatches and activates an alarm not allowing for automatic rotation).Rotoprone therapy system is equipped with four hatches located at the bottom of the patient surface, attached to the bed frame with hinges, used to access posterior of e.G.Patient for bathing, skin check tube or to perform x-ray.There are upper body hatch, hatch center bar (use for x-ray purpose), midline hatch and lower body hatch.A middle hatch gains access to a patient "middle" while proning.This hatch must be closed and latch secured before turning the patient to a supine position.User manual 208662 rev.D states: "always make sure hatches are closed and locked in position to rotating patient surface from supine/prone position and vise-versa.Use caution when opening and closing hatches.Keep extremities, hair, clothing or other objects clear of hatch openings to avoid injury or damage.Unlatched hatches and hatch center bar may pose risk of injury or damage if allowed to drop freely." the photographic evidence provided to the complaint, showed that the material where hatch is attached to the hinge separated from the hinge and this resulted in hatch dislodgement.The hatch was no longer operable and the bed needed to be replaced.The complaint has been confirmed by arjohuntleigh technician upon device inspection.The broken hatch hinge made it impossible for hatch to close posing a risk for a patient.Before the bed was placed at the facility it went through quality control check.No issue has been found, the hatches operated properly.The bed was released for rent on (b)(6) 2018 and a day later, the customer reported the investigated issue.It is unknown why the hatch hinge broke.Review of complaints for this bed did not reveal any report of hatch failure before., the bed was manufactured in may 2004, at the time of the event the bed was over 13,5 year old.,.Following an arjohuntleigh district operations manager for rental operations opinion, the hatch could have been left open and when manual rotation was used, the hatch could caught on the lower frame and got destroyed.This assumption could not be confirmed with certainty.For this reason the root cause for this failure remains unknown.Please note, that when reviewing complaint data base, we have not found another reportable complaint for this issue, the reported complaint is an isolated occurrence.In summary, when the event occurred, the arjohuntleigh device played a role in the incident as it was used for the patient treatment and failed to meet its specification.Although this event did not result in an injury, it has been decided to report it to the competent authority in abundance of caution because inability to close the middle hatch, in case the bed would be manually turned to supine position, may result in patient's unintentionally exit from the bed and a serious injury or death.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 7227303
• MDR Text Key: 98980030
• Report Number: 3007420694-2018-00023
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other