MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. BARIMAXX II; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problems Detachment Of Device Component (1104); Naturally Worn (2988)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under (b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under (b)(4).The investigation has been performed and the conclusions are as followed: the products involved in this incident is the barimaxx ii bed, which was used in conjunction with maxxair mattress replacement system.The devices are part of the arjohuntleigh us rental fleet and have been rented to customer (b)(6).The barimaxx ii therapy system is designed for bariatric patients with maximum weight of 1000 lb (455 kg).The maxxair ets mattress replacement system (mrs) was designed to be used in conjunction with the barimaxx ii bed for optimum patient comfort.The event occurred during patient transfer from barimaxx ii bed to customer-owned stretcher with assistance of 2 nurses and 2 paramedics.The bed moved and mattress tipped sideways which resulted in near fall of a patient.There was no injury to the patient.Two nurses sustained back strain.One nurse required no additional treatment or hospitalization.The second nurse has been off work on sick leave.Initially, nursing staff claimed that brakes were locked, further it was clarified that they were unaware that steering castors and castor brakes are two separate items requiring locking.This would suggest that not all wheels were locked before patient transfer, which resulted in bed movement during patient transfer.User manual for barimaxx ii #310611-ah rev.A states "precaution should be taken during patient transfer, including the locking of caster brakes and caster steering", "extra care should be taken when moving patient to and from the bed to avoid caregiver muscle strains." upon the device pick up it was found that one of the velcro strap was undone.In the course of the investigation it was revealed that one brake castor was not locked and one mattress velcro strap was not secured to the bed frame.It was stated by the nurse that velcro strap released from the frame when they were moving the patient.The mattress was pre and post placement quality control checked and no anomalous condition within the mattress was identified.Pre placement quality control for bed frame did not reveal any fault within the brake system.The bed frame evaluation after the event revealed that when force was applied to the bed frame, with all brakes locked, the bed moved slightly at the head end of the bed.The three brakes out of four required an adjustment, which would indicate that issue with brakes was related to mechanical wear.Although, the device inspection revealed that brakes held the bed partially when force was applied, in the complaint at hand two factors together contributed to the event: mattress tipping together with the bed moving.Mattress tipping was caused by hook-and-loop releasing from the bed frame and bed moving was a result of one of the brake which was not locked.Before patient placement mattress straps shall be secured to the bed frame and before patient transfer all brakes shall be verified and locked.From the above it can be concluded that the situation might be related to improper bed preparation for patient placement and transfer.In summary, the device failed to meet its specification as it was confirmed that when force was applied with all the castors located the bed slightly moved.It was being used when the event occurred and therefore, it contributed to the event.Although no serious injury occurred in relation to this event, we report this incident in abundance of caution, since the mentioned combined errors might have led to harm and create hazardous situation.This type of scenario poses a potential for adverse outcome if the failure would to re-occur.Given the circumstances and that this scenario is an isolated occurrence, arjohuntleigh do not propose any further action at this time, but will continue to monitor for any further events of this nature.

Event Description

The information provided by the customer was that during patient transfer from barimaxx ii bed to customer-owned stretcher the bed moved and mattress tipped sideways which resulted in near fall of a patient and directly resulted in back strain of two of nurses supporting the patient during the event.Further information provided was that there was no injury to the patient.Two nurses sustained back strain.One nurse required no additional treatment or hospitalization.The second nurse has been off work on 6 sick days.Nursing staff claimed that brakes were locked, further it was clarified that they were unaware that steering castors and castor brakes are two separate items requiring locking.Pictures provided by the customer, taken immediately after the event, shows that one brake castor is not locked and mattress is not secured to the bed frame with velcro strap.

• Brand Name: BARIMAXX II
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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 ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL ; 698282467
• MDR Report Key: 6562642
• MDR Text Key: 75172518
• Report Number: 3007420694-2017-00111
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2017
• 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
• Patient Age: 58 YR
• Patient Weight: 335