MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB NIMBUS 3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Device-Device Incompatibility (2919)

Patient Problem Bruise/Contusion (1754)

Event Date 03/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation has been carried out onto this incident and conclusions are following.Arjo was informed about a patient fall while he was placed on a nimbus 3 mattress.This mattress was fitted to a protean p5 premium bed frame, manufactured by the liftcare bed company and distributed by arjo in (b)(6).This event concerns a male patient, weight of (b)(6).Based on the feedback from arjo senior clinical advisor, the patient was described as "restless" when the event occurred.This incident occurred at night, and it was not witnessed.The customer staff mentioned that the night before this event, the bed frame was not working, and it was not possible to place the bed in the lowest height as the lowering feature was not working.Therefore, a nurse pushed the bed against the wall on the patient's right-hand side.It was indicated that the bed breaks were placed; however, this information was disputed by another member of the staff.Photographic evidence of the incident shows a bed away from the wall in a perpendicular position with a mattress that slipped out of bed.As per arjo complaint coordinator, the photos were taken after the event occurred and did not represent the real scenario; the bed could have been moved in order to lift the patient.Regarding the mattress position, it is visible that the straps of the nimbus 3 mattress were not attached to the bed frame.Nimbus 3 mattress instruction for use, document 151996en_05, contains information about the mattress installation.This document states that the hook and loop securing straps should be attached to the bed frame in order to secure the devices.These straps should be attached to the movable parts of the bed only.It was reported that the customer staff had previously been advised not to use this product combination.Nimbus 3 system is not recommended to be fitted with the protean p5 bed since the mattress height exceeds by about 87mm (3.5'') the recommended by the manufacturer.Arjo technician reached the customer place and confirmed the bed frame faulty.No suggestions or statements of nimbus 3 pump or mattress malfunction were reported during this event.Based on all information collected upon this investigation, it is most likely that this event was caused by not applying the brakes and not securing the straps to the bed frame.In conclusion, an arjo nimbus 3 system (both mattress and pump) was used while the event occurred, therefore it played a role in the event, however, there was no allegation of device malfunction.No serious injury was reported.

Event Description

Arjo was informed on march 23, 2019, about a patient fall from a bed fitted with nimbus 3 mattress.The description of the event states that a patient fell out of a faulty bed, which had a black wire hanging out.A staff nurse informed arjo that the night before the event happened, she could not get the bed down to the lowest position as the bed controls were not working.Therefore, the bed was pushed against the wall to the right side of the patient.The bed related in this event is a p5 premium manufactured by the liftcare bed company and distributed by arjo in (b)(6).The nurse stated that she applied the brakes; however, that information was contradicted by another member of the customer staff.Additionally, it was stated that the mattress was not secured to the bed.During the night, the male patient who presented a general medical condition described as "restless", fell between the wall and the bed, sustaining a bruise above the left eye.This fall was not witnessed, but a nurse stated that it is likely that the patient pushed the bed away from the wall with his feet causing this event.The bruise sustained did not meet the definition of a serious injury as per arjo medical expert.

Manufacturer Narrative

Removal of one sentence from the investigation conclusion as it is not related to the investigation root cause.Additionally, a cover letter is been attached concerning reportable event information on a non-arjo bed frame.An investigation has been carried out onto this incident and conclusions are following.Arjo was informed about a patient fall while he was placed on a nimbus 3 mattress.This mattress was fitted to a protean p5 premium bed frame, manufactured by the liftcare bed company and distributed by arjo in the uk.This event concerns a male patient, weight of 64,5 kg.Who was described as "restless" when the incident occurred (based on the feedback from arjo senior clinical advisor).This incident occurred at night, and it was not witnessed.The customer staff mentioned that the night before this event, the bed frame failed, and it was not possible to place the bed in the lowest position as its lowering feature was not working.Therefore, a nurse pushed the bed against the wall on the patient's right-hand side.It was indicated that the bed brakes were placed; however, this information was disputed by another member of the staff.Photographic evidence of the incident shows a bed away from the wall in a perpendicular position with a mattress that slipped out of bed.As per arjo complaint coordinator, the photos were taken after the event occurred and did not represent the real scenario; the bed could have been moved in order to lift the patient.Regarding the mattress position, it is visible that the straps of the nimbus 3 mattress were not attached to the bed frame.Nimbus 3 mattress instruction for use, document 151996en_05, contains information about the mattress installation.This document states that the hook and loop securing straps should be attached to the bed frame in order to secure the devices.These straps should be attached only to the movable parts of the bed.Arjo technician reached the customer place and confirmed the bed frame faulty.No suggestions or statements of nimbus 3 pump or mattress malfunction were reported during this event.Based on all information collected upon this investigation, it is most likely that this event was caused by not applying the brakes and not securing the straps to the bed frame.In conclusion, an arjo nimbus 3 system (both mattress and pump) was used while the event occurred, therefore it played a role in the event, however, there was no allegation of device malfunction.No serious injury was reported.

• Brand Name: NIMBUS 3
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton; houghton hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• MDR Report Key: 8531211
• MDR Text Key: 142478808
• Report Number: 3007420694-2019-00067
• Device Sequence Number: 1
• Product Code: FNM
• 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: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/28/2019
• Distributor Facility Aware Date: 03/23/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2019
• Date Manufacturer Received: 03/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 64