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

Model Number 209500

Device Problems Device Issue (2379); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A nurse reported that the buckle on the rotoprone bed could not be opened.A service technician who arrived to the facility to solve the issue was manage to open the component with a key tool.He also confirmed that the issue was not related to the buckle tension as the patient had about (b)(6) pounds, but to the female component malfunction.The faulty buckle system was replaced.There was no injury in relation to this event.The customer allegation has been confirmed.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.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.The operator of the device is to click together the male and female end of the buckle and tighten the pack straps.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.Buckle is released by pressing the button inside the 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 rental period the device had quality control (qc) checklist completed on (b)(6) 2018, no anomalies were recorded, all bed functions operated correctly.Also a service consultant stated that when he assisted in a patient placement all buckles were operating correctly.In summary, the arjohuntleigh device played a role in the event as it was used for the patient treatment.The device failed to meet its specification since inability to open the buckle occurred due to female component of the buckle malfunctioned.It is unknown why the buckle component failed.Arjohuntleigh will continue to monitor similar complaints.Although this event did not result in an injury, it has been decided to report it to the competent authority based on the potential.

Event Description

A nurse reported that the buckle got stuck and could not be unbuckled.In order to release the patient the nurse disconnected the strap from the pack, the buckle remained jammed.There was no injury in regards to the issue, the patient remained stable.

• 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: 7240406
• MDR Text Key: 99782157
• Report Number: 3007420694-2018-00030
• 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
• Type of Report: Initial
• Report Date: 02/05/2018

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: 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
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/05/2018
• 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: 82