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

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

The customer reported that they had troubles with the chest buckle on a rotoprone.No further data was provided.We are gathering additional information about the circumstances of the event.

Manufacturer Narrative

We are in the process of gathering data to this event.As soon as the information is available, a follow-up report will be submitted.

Manufacturer Narrative

Initially, the nurse reported that they called to arjo to report the investigated event around 7 february.Based on that information the initial report was submitted (9681684-2019-00019) on 7 march in order to meet the reporting deadlines.In the course of the investigation to this event, however, no evidence that event was reported to any arjo employee was found.This could not be confirmed with the customer staff (clinical nurse specialist for the intensive care unit and respiratory therapist) as well.For this reason the became aware date in g4 has been changed to 21 february.Investigation for this complaint was carried out.The conclusion is following.While gathering additional information (on 21 february)upon the course of the investigation for another complaint recorded under arjo internal number tw(b)(4), and submitted to fda under manufacturer report number: 9681684-2019-00024, a customer staff member (charge nurse) informed an arjo clinical consultant that two week ago (around 7 february) they had another patient on the rotoprone bed and they had trouble with the chest buckle on that patient.They did resolve the problem without cutting the buckle.Based on history of orders to the facility - memorial medical center, we have identified that the rotoprone bed, with a serial number (b)(4) was most likely involved in this event.The claimed rotoprone bed is a rental device, which is fully inspected in the service center after returning from each rental use.We have checked the rotoprone service history and can confirmed that it passed the requirements of both pre and post quality control, so it was performing according to the manufacturer's specification.No fault was detected, when the bed returned to service center after the event.Information that the customer were able to open the buckle after initial difficulties, indicates that the reported issue was related to the tension built on the buckle release mechanism.Tension is built on the buckle release mechanism due to straps overtightening, or the patient can 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 tension built on the buckle mechanism made it difficult to open.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.

• 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: 8399465
• MDR Text Key: 139584875
• Report Number: 9681684-2019-00019
• 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: company representative,user f
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0802-2019 / 81872
• Patient Sequence Number: 1
• Patient Outcome(s): Other