MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MINUET; FNL

Model Number 160AA2A1A

Device Problems Migration or Expulsion of Device (1395); Use of Device Problem (1670); Facilities Issue (2935)

Patient Problems Death (1802); Fall (1848); Skull Fracture (2077)

Event Date 12/29/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for devices from the same device range, we have been able to conclude that this complaint is considered to be a single, isolated event at this time.The device involved in this incident was established to be the minuet 2 bed, model 160aa2a1a , serial number (b)(4), which was manufactured on 2011-08-26.The device history record has been reviewed; no anomalies were recorded at the time of manufacture.Review of complaint data revealed that there have been no complaints registered under this serial number.The device has been in use over the five years before the event occurrence.Based on the all information gathered, we have been able to conclude that the customer allegation was that the patient fell from the bed due to the brakes nearest the wall not having been applied.According to the customer the inability of using the brakes was related with how the bed was set up in the room.We have recreated this situation in the laboratory environment and are able to conclude the following: it is possible with not much effort, to apply all four brakes on castors, even though the bed is placed along the wall.After setting the bed in mentioned position, there is an access to the brakes that are next to the wall.The instruction for use (#746-396-uk rev.6 dated on february 2010 ) provides all necessary information regarding usage of the brakes.It also warns the user about necessity of applying all 4 brakes to prevent the bed from moving while in use with a patient.Knowing the condition of the patient, it is also realizable to set the bed in the very low position, which would be the most secure height.The lowest level can be set in approximately 28 cm of height.The bed has been placed in the lowest possible position in order to recreate the height from which the patient has fallen.During the issue occurrence the bed was in use with a mattress (unknown what type).According to the instruction for use for minuet 2 a mattress can have max.12,5 cm.Therefore, the maximum height from which the patient could have fell is establish to be +/- 40 cm.Moreover, the ifu warns the user that the bed should be lowered to the minimum whenever the patient is left unattended.The force needed to move the bed from the wall is strictly correlated with an actual load applied on the bed and coefficient of the friction between castors and floor.With the limited information provided, we were unable to recreate the same conditions as during the event occurrence, but we did manage to perform a test to estimate the force needed to push the bed from the wall while (b)(6)person is lying on the bed and it is placed on the slippery base.During the test, it was concluded that a relatively big force (450n) is needed to push the bed away from the wall and this activity was described as hard by the person involved in test.Taking into the consideration that the patient, who was involved in this particular event, was diagnosed with dementia and had no upper body stability, it seems not likely that a gap between the wall and bed frame has been created in an immediate manner, without a significant effort from the patient side.The minuet 2 bed device can be used with a safety sides panels, that act as an mechanical barrier for the patient to reduce the possibility of unintentional exit from the bed.They are however not intended to restrain patients who make a deliberate attempts to leave the bed.Please note that this is an optional function proposed for this bed and the decision whether to use it or not should be made by a qualified personnel.As per the instruction for use provided for this particular bed (#746-396-uk rev.6 dated on february 2010 ), a clinically qualified person responsible is to consider the size, age and condition of the patient before allowing the use of safety sides.Additionally, according to the information received from the bed owner, we conclude that all four brakes were fully functional when the event occured, moreover, it remained unknown whose decision was not to use the safety side panels with this particular patient.In summary, upon the conducted investigation, we have confirmed that device did not fail to meet its specification.The event occurred during a patient treatment, therefore it did play a role in the incident.Based on the performed investigation, it seems that the patient was assessed as unsuitable for safety side use due to her condition.Additionally, the user placed the bed in the lowest position and with mattresses on the floor.Putting the bed in lowest position is not uncommon but placing mattresses on the floor is not considered normal clinical practice.It appears to indicate either the expectation from the user that the person would attempt to leave the bed intentionally or at minimum that there were circumstances relating to the use of the bed that were not shared with the manufacturer.The root cause for this event was found related to the combination of carer's using technique and patients' health state including preexisting conditions.The complaint was decided to be reportable to competent authorities based on a patient outcome.Given the circumstances, it has been decided to provide a feedback to the customer and recheck if user manual is available with the device.We shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Initially, arjohuntleigh has been informed about following incident: the patient was provided a hoist and as standard practice patients who require a hoist also require a hospital bed.The patient did not have sitting balance and due to her medical conditions, she appears to have been evaluated as not suitable for a care situation involving the use of bed rails.At the customer home, it was indicated to us that the bed was placed against a wall to act as a barrier and the bed was put to its lowest height with a mattress on the floor, so that the patient should fall out of bed it would not be from a high level and would fall onto something soft, thus reducing risk of injury.Due to the way the bed was placed, it was indicated to us that the only brakes that could be applied were the ones on the opposite side of the wall.The patient leant against the wall and as the bed was unstable, it is alleged to us the patient's body acted as a lever and pushed the bed away from the wall.Consequently, the patient fell in between the bed and the wall.According to the coroner's letter, it has been revealed that the patient was a female, aged (b)(6) years who had been diagnosed with dementia and the cause of her death was head injuries, namely a fractured base of skull and intracranial bleeding.

• Brand Name: MINUET
• Type of Device: FNL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78219 ; 2103170412
• MDR Report Key: 5499929
• MDR Text Key: 40300340
• Report Number: 3007420694-2016-00032
• 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: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/15/2016,02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 160AA2A1A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2016
• Distributor Facility Aware Date: 02/15/2016
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 03/15/2016
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2011
• 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
• Patient Age: 92 YR