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

Model Number 209800-R

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2019

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 kinetics concept inc (under registration #(b)(4)).From november 2012 until 2014 complaints related to these products were handled by arjohuntleigh inc.And any medwatch reports were submitted under registration #(b)(4).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 #(b)(4).From 30 may 2018 medwatch reports will be submitted under registration #(b)(4).Investigation for this complaint was carried out.The conclusion is following.The customer stated that the strap of the buckle chest pack was cut as a patient experienced emergent respiratory event during therapy.A medical doctor who was present during the event wanted to intubate the patient.The customer staff attempted many times to push down on the packs on both sides to loosen the chest buckle.As buckle could not be opened and the patient was desaturating, the staff decided to cut the strap.No injury was reported.Arjo technician assessed the buckle system and found that the buckle mechanism worked as intended (the buckle could have been opened and closed without problem).Some scratches were visible on the red button of the buckle, which had not influence on the buckle proper functioning.Based on the provided photographic evidence and taking into account that rotoprone system passed quality check before being delivered to the customer, it could be concluded that these scratches were left most likely after trying to release the buckle with a sharp object.Both male and female buckle parts were replaced due to this esthetical defect.Although some scratches were left on the red button, there was no mechanical failure of the buckle, thus arjo concluded that the most likely cause of the buckle inability to open was related to the tension built on the buckle release mechanism (due to straps overtightening before the proning therapy or the patient could swell and push on the proning packs which generates extra tension in the straps).In summary, arjo rotoprone system played a role in the event as it was used for patient treatment.During this event, the device failed to perform as intended as buckle could not be opened due to tension built on the buckle mechanism.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

Arjo was informed about an event with rotoprone system at saddleback memorial medical center.The customer stated that the chest buckle strap was cut as the patient experienced emergent respiratory event during therapy.The customer staff attempted many times to push down on the packs on both sides to loosen the chest buckle.As buckle could not be opened and the patient was desaturating, the staff decided to cut the buckle.After releasing the packs, the patient was placed on a regular bed, where was tolerating the supine position.The medical doctor discontinued the rotoprone therapy.

• 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 ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 8436196
• MDR Text Key: 139337780
• Report Number: 9681684-2019-00024
• 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: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209800-R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/20/2019
• 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
• Removal/Correction Number: 9681684-12/21/18-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other