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

Model Number 209800

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.It was reported by the customer that the buckle of the rotoprone bed fell apart while trying to open the buckle to release the patient, while device was placed in the supine position.The nurse decided to leave the patient in prone position until the arjo service technician arrival as the patient condition required it.In the complaint, the allegation was that the buckle fell apart while trying to release it and the nurses could not open it.When arjo service technician arrived to the facility, he noticed that red button on the buckle was missing.He was trying to open the buckle with the mechanism that was left but failed.Therefore, he decided to cut the strap to release the patient.The patient was transferred to a new bed.After the event, the rotoprone bed was returned to the service center.The buckle was replaced and the defective buckle was disposed of.It is worth pointing out that the buckles are used to restraining a patient on the rotoprone when the patient is in supine or prone therapy.User manual (#208662-ah rev.D), which is provided with each device, contains all crucial warnings, cautions and instruction.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).Rotoprone system was quality checked before being delivered to the customer; in this order, the asset was placed at the facility without defects.The involved in the event patient size was described as "small" and based on this information it can be assumed that the issue was not related to the buckle tension.After the event the buckle system was replaced.In conclusion, arjo rotoprone system played a role in the event as it was used for patient treatment and failed to perform as intended as buckle could not be opened.The incident was caused by the mechanical failure of the buckle (fail to meet manufacturer specification).It is unknown however why the buckle failed.There was no injury reported in relation to this event.We report this incident to the competent authority because of potential for health impact if it recurs.

Event Description

It was reported by the customer that the buckle of the rotoprone bed fell apart while trying to open the buckle to release the patient, while device was placed in the supine position.The nurse decided to leave the patient in prone position until the arjo service technician arrival as the patient condition required it.In the complaint, the allegation was that the buckle fell apart while trying to release it and the nurses could not open it.When arjo service technician arrived to the facility, he noticed that red button on the buckle was missing.He was trying to open the buckle with the mechanism that was left but failed.Therefore, he decided to cut the strap to release the patient.The patient was transferred to a new bed.

• 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: stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 8419701
• MDR Text Key: 142626371
• Report Number: 9681684-2019-00020
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 209800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/14/2019
• 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