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

Model Number 209800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Physical Entrapment (2327); Unintended Extubation (4564)

Event Date 06/25/2021

Event Type  Death  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).Currently, these products are to be handled by arjohuntleigh abs complaint handling establishment and any medwatch reports will be submitted under registration # (b)(4).Based on all collected information it was determined that there has not been indication of any bed malfunction or any indication of inability to use any of the device functions at the time of the event.The patients et tube was disconnected on both patients and ventilator side for unknown reason.If new information influencing the cause of the event becomes available, a supplemental report will be provided.Arjo device was used for a patient treatment when the event occurred and from that perspective it played a role in the event.The complaint is deemed reportable due to allegation of patient's death during use of rotoprone bed.

Event Description

Arjo received a complaint on rotoprone bed alleging that the patient died while being on the rotoprone.Prior to the incident the patient was in prone position for 6 hours, all buckles were secure, ras-4, vital signs were consistent.30 minutes before the incident was noticed the nurse attended the patient in the room.The nurse came back to the room as the alarms for monitors went off and found that the patient became malpositioned in the bed: patients head was out of head pack, knee was between the buckles, hands up out of the bed.It was stated by the customer that the patient became disconnected from the endotracheal tube, and the endotracheal tube also became disconnected from the ventilator.The facility staff was concerned that the patient could have sustained the c-spine injury, so they decided to remove the patient from the bed, while the patient surface was still in prone position instead of rotating back to supine position, not to injure the patient.Caregivers placed the patient in prone position to the floor, then supined and started cpr.Patient passed away.

• 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: 12232287
• MDR Text Key: 263797246
• Report Number: 9681684-2021-00041
• 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: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209800
• Date Manufacturer Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2005
• 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): Death