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

Model Number 209500

Device Problems Use of Device Problem (1670); Misassembly During Maintenance/Repair (4054)

Patient Problem Extubate (2402)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).Currently, this product is to be handled by (b)(4) complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).Additional information will be provided when investigation conclusion is available.

Event Description

It was reported by the customer that a suction line, which was not secured and was hanging along the bed, was caught by the bed and extubated from the patient, when the bed was rotating.A nurse stated that the patient coded but they were able to emergently place the bed in supine position and get the patient intubated again.

Manufacturer Narrative

Arjo received information from a nurse that when their patient was in prone position rotating side to side, the suction line was caught by the bed and as a result the suction line extubated from the patient and the patient coded.Nurses brought back the bed to supine position and were able to intubate the patient again.Following customer statement, the suction line was not secured in tube management system (tms) and was dragging along the hoop.The tms is bed¿s part where all tubings and lines are placed outside of moving bed¿s mechanism and to ensure the lines are not caught by the bed mechanism.In the course of the investigation and basing on photographic evidences provided by the customer, it was discovered that a plastic part (molded inner trim) was incorrectly attached to the bed (zip ties were used instead of screws).This created a gap between the bed and plastic part where the suction line got caught.Product instruction for use states: - ¿tube and line management - prior to activating rotation, assess the security of all invasive lines and tubes to accommodate a full 360° of rotation and minimize the risk of binding, disconnecting or dislodging.Tubes and lines should always have slack for rotation and patient movement.Tubes and lines must always be routed through and kept within either top frame hoop or the circular opening in the frame at the foot-end of the unit, just beneath¿.- ¿position patient support equipment: route ventilator tubes and other upper-body lines out of head-end of unit through open top frame hoop.Secure all lines and tubing in tube management system at head of unit.¿ -¿ensure all lines have adequate slack to avoid pulling or tangling during rotation.Ensure lines and tubes fit in tube management system holes and can slide freely without being pinched, kinked or compressed.¿ for the incorrectly attached plastic part an action was addressed to eliminate detected nonconformity.In summary, the bed was used for patient treatment when it failed to meet its performance specification.Two factors were found that led to reported event: 1) the suction line was not secured; 2) the plastic part was incorrectly attached to the bed.We report this event because of serious injury (the extubation and subsequent coding).

• 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: 10267856
• MDR Text Key: 198696649
• Report Number: 9681684-2020-00042
• 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
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 06/18/2020
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention