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

Model Number 209500

Device Problems Cut In Material (2454); Separation Failure (2547); Human-Device Interface Problem (2949)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A nurse from (b)(6) hospital customer facility called via linc (learn, initiate, navigate and connect) program for the rotoprone¿ therapy system stating that the buckle on rotoprone is "cracked on the side and "broken'".The information reported presented a concern that in case of emergency the buckle would not release.Arjohunteleigh service technician who arrived to the facility to solve the issue decided to cut the strap since he could not open the buckle either.When the strap had been cut, the pressure on buckle release mechanism loosen and the buckle could have been opened without issue.Buckle release mechanism was operating correctly.There was no injury in relation to this event.When reviewing reportable events for the rotoprone therapy system we were able to establish that there have been a low number of similar complaints in the past, there is no trend observed for this failure mode.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.When securing packs during patient placement, straps need to be tighten.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.To do this one hand is pushing down on pack and the other hand is pulling the strap to yourself.It may happen that the strap has been tighten to the moment the buckle cannot be opened because of the tension built on the buckle release mechanism (buckle is released by pressing the button inside the buckle).In order to release the buckle the tension needs to be reduced.In the reported event, after the strap was cut out, the buckle was tested and operated correctly.This indicates that there was high enough tension on the buckle release mechanism which made difficult for clinician to push the red button to open the patient buckle.User manual (#(b)(4)), which is provided 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.Prior to renting period the device had quality control (qc) checklist completed on 28th august 2017, no anomalies were recorded, all bed functions operated correctly.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 authority based on the potential and in abundance of caution.

Event Description

A nurse called stating that the buckle on rotoprone is "cracked on the side and "broken''".The information reported presented a concern that in case of emergency the buckle would not release.The issue was noticed by a nurse when the patient was put into supine.The patient saturation level was dropping so the nurse place the surface in prone position.There was no injury in relation to this event.The issue could not have been resolved by a phone, therefore a service technician was dispatch to the facility to assist the nurse and resolve the issue on site.A service technician decided to cut the strap since he could not open the buckle, as well.After the strap was cut out, the buckle release mechanism was tested and operated correctly.The strap was replaced.

• 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
• MDR Report Key: 6896633
• MDR Text Key: 89470200
• Report Number: 3007420694-2017-00199
• 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: user facility
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2017
• 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: 118