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

Model Number 209500

Device Problems Component Falling (1105); Difficult To Position (1467); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A nurse called stating that the patient was re-intubated and the tube management system was not tighten in place and fell, pulling on the tubings.The decision was to put the patient into prone position but monitor the tube management system closely during rotation so that the tubing does not get pulled.

Manufacturer Narrative

The investigation was performed and the conclusions are following: initial allegation was that the knob did not tighten enough to secure tube management system (tms) in place resulting in tms falling down and pulling on invasive line.On 20 march 2018 additional information received was that, before a technician called to the facility to help with the reported issue, the nurse informed that she had tighten the knob and secured tms in place.Tube management system (tms) is used to route invasive lines out of the head-end of unit and through open top hoop.Tms holds tubes in place during rotation.The tms is using knobs that tighten it to the frame.The rotoprone asset was quality control (qc) checked before the delivery to the customer on 10 february 2018 and when it returned from the rent on 27 february 2018.On both occasions no issue was detected.No fault with tms or knobs were found.The tms operated correctly and, as indicated by the nurse, it could have been secured as intended.Rotoprone user manual 208662-ah rev.D includes following information about tube management system: "tube management system may fall if knobs are loosened too far.Support the system as knobs are loosened." "raise tube management system: swing tube management system up and hold in place.Tighten black knobs contralaterally on each side." "ensure the tube management system in secure and does not swing back down into the unit frame.Ensure that tubes and lines do not catch or become tangled." from the above it can be concluded that the root cause of the issue was related to knobs being no tighten enough.We reported this complaint based on initial information received suggested that the tms failed and yet it was still in use.On 20 march 2018 we have been informed that when a technician called the nurse, the same day the service request was ordered, to assist further with tms issue, he was informed by the nurse that they were able to tighten the knob and the tms was holding in place.In the examined risk analysis documents we have found point which concerns reported incident.If user does not twist black knobs on each side of the tms until it is firmly locked into place, the potential hazard could be "inadvertent removal of invasive lines" and potential harm "transient physiological decompensation".The severity has been assessed as 2 - limited - transient, self-limiting illness or injury (could cause temporary discomfort) and the probability of occurrence has been assessed as 2 - rare - unlikely (feasible, but unlikely in common use).A review of customer complaints for rotoprone device showed that the rate of occurrence of events where the customer did not tighten the knob is 0,02% (2/9615 within the last 2 years from february 2016 till february 2018), which means 1 rate of occurrence based on rotoprone product family risk plan.There was no injury in relation to the events reported (severity 1).The expected and observed frequency and severity for the reported event is considered as being in line with our design and risk management files and we do not expect that the reported event will reoccur with greater frequency or severity in the future.In summary, the device was use for patient treatment when the event occurred, but did not cause or contribute to an adverse event and is not likely to result in hazardous situation in the future.The device did not fail to meet its specification since the knob was tighten by the nurse and tms could have been secured in place.This complaint was reported to competent authorities based on initial information, however upon receiving additional information, it was concluded that this incident does not meet the definition of mdr adverse event and will not be considered as such in the future.

• 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: 7341694
• MDR Text Key: 103153355
• Report Number: 3007420694-2018-00066
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 03/20/2018
• Supplement Dates FDA Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other