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

Model Number 209500

Device Problem Defective Component (2292)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Bed returned to service center after end of rental period where was evaluated.The cable hoop switch was found defective.The hoop switch is responsible for detecting if the hoop gate is opened or closed.If the hoop switch sends a signal that the hoop gate is opened, the rotoprone patient surface cannot be rotated electronically, as the alarm will prevent electronic rotation.But the patient surface can be rotated manually.Technicians confirmed that they were able to perform a manual rotation without any issue.Nurse¿s allegation that the bed stopped at 62 degree of rotation was most likely related to the manual rotation lever which was not activated as instructed by the device labelling.At the foot end of the bed, there is a manual rotation lever that must be lifted in order to go past 62 degrees, from supine to prone.Instruction for use #208662-ah and labelling attached to the foot end plastic, guide through manual rotation to prone position.Labelling instructs to: "disengage emergency release handle, if necessary; break tab to open door and access manual rotation lever; lift and hold manual rotation lever for duration of manual rotation; instruct person 2 and 3 to rotate patient to prone position; release manual rotation lever and re-engage emergency release handle".Before the bed was delivered to the customer, it was checked during the quality control and passed functional tests.No discrepancies were found.In summary, at the time of the reported event, the bed failed to meet its performance specification since cable hoop switch was found defective what triggered the alarm.But this electrical failure did not influence manual rotation features (this was confirmed during bed¿s evaluation).Although manual rotation feature was not used by the nurses, they were aware of the situation and decided to take the patient out of the rotoprone to manually prone on a regular bed.It is unknown if delay in prone therapy influenced decrease of the oxygen level, therefore this event was deemed reportable with an abundance of caution.

Event Description

It was reported to arjo by a nurse that an open hoop alarm activated after patient was placed in supine position.The nurse was trying to troubleshoot and clear the alarm but unsuccessfully.An arjo representative who assisted the nurse was attempting to guide the nurse through manual rotation to prone but the nurse stated the bed would not rotate past 62 degree.Patient was desaturating quickly so the nurse decided to transfer the patient to another regular bed and prone manually to stabilized the patient.There was no suggestion from the customer that the delay in prone therapy might result in lower oxygen level.The oxygen saturation only went down to the 80s%.

• 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 ; 688282467
• MDR Report Key: 10332443
• MDR Text Key: 215615315
• Report Number: 9681684-2020-00044
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/28/2020
• 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