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

Model Number 160CA2A1A

Device Problem Device Tipped Over (2589)

Patient Problem Fall (1848)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

The process of gathering information is ongoing.Additional information will be provided upon conclusions of the investigation.

Event Description

On (b)(6) 2019 arjo was informed about the event, which occurred in (b)(6).Following information reported, two carers provided personal care to the resident.One carer moved away from the bed and the bed tipped over to one site.As a consequence, the resident fell to the floor with trapped arm.The patient was taken to the hospital after the event.Details regarding injury were not reported.If more information is available, it will be provided to the follow-up report.

Manufacturer Narrative

Initial reporter name (section e1); manufacturer name (section d3 and g2); age at time of event (section a2) were changed in this report.Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjohuntleigh, a branch of arjo ltd.Med ab (under registration #3003984900).As of 2011, that number was de-activated due to the site no longer being a manufacturer and shipping product to the usa and until 2014 complaints related to these products were handled by arjohuntleigh, a branch of arjo limited med ab and any medwatch reports were submitted under registration #1000381138.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #3007420694.On 20 jun 2019 arjo has been informed by amberley court care home in bupa about the incident involving arjo medical bed: minuet 2.It was reported that minuet 2 bed tipped over to one side and as a consequence, the resident fell to the floor.The involved resident was 59 years old male weighing 101 kg, who was incapable of performing daily activities without assistance due to a paralyzed part of the body (down right-hand side).Before the incident happened, two caregivers were providing care to the resident.When one of them, moved away from the bed, the unfortunate incident took place.After this event, the resident was taken to the hospital with the suspected fractures, however this preliminary diagnosis has not been confirmed.After the examination, it was confirmed that the resident sustained facial injuries and bruised arm.After receiving information about the event, arjo service technician was dispatched to conduct the device inspection.The device evaluation did not reveal any device malfunction.The functional test was carried out and the bed was working in accordance with the specification.Amongst others, the operation of the safety side rails and brakes were checked.There was no issue found.The results of the evaluation confirmed that there was no device malfunction, which could contribute to the reported failure - bed tipping over.Based on the further information gathered by arjo technician, the partially paralyzed resident used safety side rails to adjust his position in the bed.It can be suspected that when the patient leaned against the safety side rail, the patient's weight was loaded on the safety side rail (locked in the raised position) from one side of the bed, which could contribute to the bed's tipped over.The facility staff did not provide any details regarding circumstances of the event.The safety side rails are the components placed on both sides of the bed.They prevent resident from rolling or falling out of the bed.The instruction for use dedicated to minuet 2 bed (746-396) warns: "before operating the bed, make sure that the patient is safely positioned to avoid entrapment or imbalance".When this warning is followed, the risk of any hazardous situation is mitigated.It needs to be also pointed out that arjo minuet 2 medical beds were certified for compliance to the international standard iec 60601-1 that confirms stability of the device in normal use.Based on all collected information, arjo has been unable to identify the exact cause of the reported event.However, in light of all information gathered, device design or malfunction was excluded as a potential contributing cause of the reported resident's fall.In summary, the complaint was decided to be reportable due to the allegation of the device tipping and patient's fall which caused the injury.The device was being used for patient care at the time of the incident.The device was reported to tilt and from that perspective, the minuet 2 bed did not work as intended.

• 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
• MDR Report Key: 8783710
• MDR Text Key: 150855406
• Report Number: 3007420694-2019-00115
• Device Sequence Number: 1
• Product Code: FNL
• 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: 08/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 160CA2A1A
• Was Device Available for Evaluation?: Yes
• Device Age: 12 YR
• Date Manufacturer Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 101