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

Model Number 209800

Device Problem Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: 1625774, 3010048749, 3009988881, 3007420694.Currently, this product is to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration 9681684.A supplemental report will be submitted once investigation conclusions are available.

Event Description

The customer contacted the arjo clinical consultant because the rotoprone bed could not be placed in the prone position and was making a clicking noise.It rotated to about 30 degrees before stopping.No alarm or error message was present.It was indicated that the patient's o2 saturation was in the 80's but nothing in the complaint stated that the lack of the bed's rotation caused the decrease in o2 saturation for the patient using a balloon pump.No serious injury was reported.The issue could not be resolved by the phone, therefore, another device was ordered for the patient.During the follow-up call, the customer representative informed that a hospital clinical specialist was able to get the surface prone.

Manufacturer Narrative

Process of analyzing information is ongoing and the final conclusions are not available at this time.Additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

The involved device was picked up from the customer and inspected.The issue with moving the device to the prone position was detected.The ribbon cable had been stressed by manually moving the rotoprone base in the wrong direction, the toggle assembly was no longer aligned, there was also evidence that the manual rotation was used because the tie-down was broken.Product instruction for use 208662-ah rev.E indicates to always rotate the patient surface from the supine position towards the ventilators.¿manually rotate patient surface to supine position in the opposite direction from which the unit was proned (¿) assess tubing to determine appropriate rotation direction to prevent twisting tubes or pulling tubes from patient.¿ when the clockwise rotation is selected, the patient surface will rotate from supine to prone in the clockwise direction.When directed to return back to supine from prone, the patient surface should rotate in the counterclockwise direction.As the customer was able to move the device to prone and informed that the bed was working fine, it is unknown when the reported failures occurred.Based on the collected information it is unknown why the customer experiences difficulties in moving the device to the prone position during the patient's therapy.Finally, the customer was able to move the device to prone and informed that the device worked fine.The rotoprone bed failed to meet its specifications, the device inspection confirmed the issue with the rotation.The claim was assessed as reportable in an abundance of caution.The patient's o2 saturation was in the 80's, there was no indication that a serious injury occurred.Later the patient died.There was no suggestion from the customer that the claimed issue may have resulted in the low oxygen saturation and later death.No suspected association between the low saturation, the death and the use of the product based on the currently available information was found.

Event Description

The customer contacted the arjo clinical consultant because the rotoprone bed could not be placed in the prone position and was making a clicking noise.The device rotated to about 30 degrees before stopping.No alarm or error message was present.The patient's o2 saturation was in the 80's, but there was no indication that a serious injury occurred.The involved patient could not transferred to another bed to be manually moved to the prone position because the patient was using a balloon pump.The issue could not be resolved by the phone, therefore, another device was ordered for the patient.During one of the follow-up calls, the customer representative informed that finally, a hospital clinical specialist was able to get the surface prone.No details were provided explaining how the issue was resolved.When another device was delivered to the customer, the nurse informed that the claimed bed was working fine.Later the patient died.The cause of the patient's death is unknown.There was no suggestion from the customer that the use of the device may have resulted in the low oxygen saturation and later death.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17779336
• MDR Text Key: 323793684
• Report Number: 9681684-2023-00065
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2006
• 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
• Patient Sex: Male
• Patient Weight: 129 KG