MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD. MED. AB MINUET 2; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number UNKNOWN

Device Problem Entrapment of Device (1212)

Patient Problems Fall (1848); Physical Entrapment (2327)

Event Date 02/08/2022

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the registration number (b)(4).Currently, these products are to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).The investigation is ongoing.Results of the analysis will be provided to the follow-up report.

Event Description

Arjo became aware of an event involving an arjo minuet 2 bed frame and non-arjo accessory sidhill elland grab rail.It was reported that the patient had fallen from the bed frame during the night on the handset controller which activated a lowering movement of the bed frame.The event resulted in the patient's neck entrapment under the bed.The patient was found in the morning by her caregivers.The handset controller could not be found therefore the bed frame was physically lifted off the patient and the emergency services were called.The swollen patient was transferred to the hospital.At this time, it is not clear what injuries the patient sustained.The family member informed that the patient never recovered, became bed bound and died of covid contracted in the hospital.

Event Description

Arjo became aware of an event involving an arjo minuet 2 bed frame and non-arjo accessory sidhill elland grab rail.It was reported that the community patient fell from the bed during the night on the handset controller which activated a bed lowering function.The patient was found in the morning by caregivers entrapped by a neck under the bed frame.The caregivers physically lifted the bed to release the patient and called the emergency services.The swollen patient was transferred to the hospital.The information about sustained injuries was not revealed.The family member informed only that the patient never recovered, became bedbound, and died of covid contracted in the hospital.

Manufacturer Narrative

Arjo became aware of an event involving an arjo minuet 2 bed frame and non-arjo accessory sidhill elland grab rail.It was reported that the community patient fell from the bed during the night on the handset controller which activated a bed lowering function.The patient was found in the morning by caregivers entrapped by a neck under the bed frame.The caregivers physically lifted the bed to release the patient and called the emergency services.The swollen patient was transferred to the hospital.The information about sustained injuries was not revealed.The family member informed only that the patient never recovered, became bedbound, and died of covid contracted in the hospital.The involved bed frame is the property of nrs healthcare.They advised that the bed frame was returned to them following the event and was inspected.No defects were found therefore it was put out for re-use and it is currently with another client.It is unknown why the patient fell from the bed.From the letter written by the family member, arjo acknowledged that before the reported event occurred, the involved patient had some recent falls at home (following illness and conditions with her heart and kidneys) therefore we may suspect that the reported fall was related to the patient¿s medical condition.The patient was entrapped under the bed because she fell on the handset controller which activated the bed frame lowering function.The bed frame descended to its lowest position which in the assessment of the family member was too low.The space between the floor and the bed frame in the lowest position equals 8 inches/ 20.3 cm from the floor.The arjo bed frame had installed a non-arjo accessory: sidhill elland grab rail (this accessory was designed to assist the user to reposition themselves in bed or to transfer out of bed).The space between the grab rail tightening knob (used to install the accessory to the bed frame) equals 5,5 inches /13,97 cm from the floor.The involved bed is compliant with standard iec 60601-2-52, which specifies the requirements for trapping zones within the bed.According to clause 201.9.2.2, the clearance area between moving parts and the floor should be more than 12 cm.Arjo bed met this requirement.According to minuet 2 instruction for use (746-396-uk): ¿before operating the bed, make sure that the patient is safely positioned to avoid entrapment or imbalance.¿ ¿lower the bed to minimum height whenever the patient is left unattended.¿ ¿do not use accessories that have not been designed and approved for use with the bed.¿ based on the information gathered it is concluded that an unintentional activation of the bed¿s lowering function that occurred at the time of the patient fall from the bed resulted in the patient¿s entrapment under the bed.Arjo device failed to meet its performance specification since the patient was entrapped under the bed frame.The complaint was assessed as reportable due allegation about the patient's fall from the bed frame which resulted in the patient's entrapment.The involved patient required hospitalization.

• Brand Name: MINUET 2
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD. MED. AB; unit 3 britannia park, trident drive; wednesbury WS10 7XB; UK WS10 7XB
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD. MED. AB; unit 3 britannia park, trident drive; wednesbury WS10 7XB; UK WS10 7XB
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15325834
• MDR Text Key: 298949207
• Report Number: 3007420694-2022-00140
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2009
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Female