MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. BARIAIR; FNM

Model Number 404000-R

Device Problems Deflation Problem (1149); Insufficient Information (3190); Device Handling Problem (3265)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

On august 3, 2016 arjohuntleigh was informed about a patient, who developed deep tissue injuries to the buttocks, lower and upper back while being on a bariair bed.According to the nurse the bed was not functioning correctly since the inflation pump shut off without notice.

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site kinetics concept inc (under registration#(b)(4)).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc.And any medwatch reports were submitted under registration # (b)(4).From november 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4)'s complaint handling establishment and any medwatch reports will be submitted under registration # (b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

Additional information received, thus far, are as follow: the customer bought a used/refurbished bariair bad, which failed.The loaner bed was picked up from arjohuntleigh warehouse in (b)(4) and delivered to the client house located in (b)(6) as a replacement, however, according to the rehab and mobility systems representative, which delivered the bed, the mattress surface could not be inflated property.The used/refurbished bed was evaluated in the service center.It was found: the bed has marks that would indicate that the maintenance was performed by a third party, the controller post (user interface) was functional with the exception of articulation control (frame motion functions).Extensive damage to the foot support assembly was found.Two hydraulic dampers and the spring restraint assembly found detached along with frame-tear at their mounting point.The unit was tested with 440 lbs weight applied on the seat section and with raised head section.It was found that although the air pressure needed to be increased, the surface kept the weight from touching the hard surface beneath the cushions.

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for bariair devices, we have observed no trend with the allegation of patient developing deep tissue injury due to incorrect pressure adjustment.On august 3, 2016 a facility reported to their arjohuntleigh representative that a patient developed deep tissue injuries to the buttocks, lower and upper back.It was alleged that the device air pressure pump stopped working without notice and that the patient frequently was sitting on the frame.Additionally, it was stated that the bed lowered automatically when raised to a certain degree - it was alleged that the patient condition ((b)(6), tracheotomy) required the bed to be at a certain angle.The device involved in the alleged event could not be identified with certainty.We have been able to narrow down the possibilities to two bariair devices, model number: 404000-r.One device has serial number: (b)(4), it is a device that has been refurbished after being part of the fleet of rental devices.The device was sold to rehab and mobility systems on september 2, 2015 and further shipped to a single family house located in ann arbor.On july 20, 2016 a "loaner" bed was delivered to the customer in exchange to the sold one, as the sold device failed.According to the rehab and mobility systems representative, which delivered the loaner bed, the mattress surface could not be inflated property.Both devices before being released to the customer, were checked and passed the requirements of quality check inspection.The refurbished/sold bed went through preventive maintenance inspection on september 17, 2015 to ensure that its functions work correctly.The loaner bed was checked two days before being delivered to a customer and no issue had been found.The information regarding the stage of tissue damage has not been revealed, however it was communicated that the patient had no skin breakdown before function issues with the bed occurred.According to user manual, regularly monitoring skin condition will prevent serious skin breakdown.It is suggested to consider alternative therapies for high acuity patients if necessary.Performed evaluation of the refurbished/sold bed revealed that the pressure setting were tracking normally.When 440 lbs was applied to the setting adjustments made by the last user, although the air pressure needed to be increased, the surface still kept the weight from touching the hard surface of the bed.No anomalies have been found in regards to pump issue.It is worth mentioning that the blower was replaced before the bed was sold to the customer.From the device evaluation we have learnt also, that it is most likely, that an outside party performed bed maintenance.This despite the recommendation from user manual that preventive maintenance procedure is to be conducted by arjohuntleigh service personnel or arjohuntleigh approved personnel.Some screws were missing, the labeling of communication cable was not arjohuntleigh's.The controller post was not functional in regards to frame motion functions.Please note, that the bed has two corner post to which controller can be installed.The right corner post was found to have damaged connectors, which disrupted articulation communication to the left corner post.Damages to the foot support assembly were found and two hydraulic dampers were detached along with frame-tear at the mounting point.The damage to the corner post could have influenced bed function articulation, however, the allegation that the bed lowered automatically, as stated by a technician, was most likely, related to customer being not aware of how the device works.The bed is designed to tilt back the frame (trendelenburg) when the head section is raised in order to prevent a patient from sliding toward the foot end of the frame.The loaner bed was checked at detroit service after the event and no issues have been found which would confirm the allegation of improper bed inflation.There was found that the cpr was not working correctly, however this issue is not related to the allegations.Taking into consideration all the circumstances of the reported event, it is possible to indicate several factors contributing to patient's outcome: monitoring not properly adjusted to the patient's condition, improperly performed preventive maintenance, air pressure improperly adjusted.Damage to the bed components: corner post, detachment of the dampers are not related to the event.The beds were checked before being delivered to the customer in order to ensure its proper functioning and passed all the required functional tests.The devices evaluation after the event have not confirmed the customer allegation regarding issues with the blower or insufficient air flow that would suggest the relation to the event.Correlation between patient's injury and device issues could not be proven.Although, no clear information which bed could cause or contribute to the event, has been provided, basing on the above, we were able to list several factors that could result in patient outcome: skin monitoring not adjusted to patient's condition, rough handling of the bed (including unauthorized device modifications), misinterpretation of bed functions and improperly adjusted of pressure accordingly to the patient's weight and needs.In summary, although it has not been clarified which bed actually might have caused or contributed to the even, it can be stated that the devices failed to meet its specifications.Complaint was decided to be reportable based on the allegation of patient developing tissue damage.In the course of the investigation, however, it was confirmed that the issues found within the bed could not have resulted in patient's developing tissue damage.Given the circumstances, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: BARIAIR
• Type of Device: FNM
• 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: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5917067
• MDR Text Key: 53565779
• Report Number: 3007420694-2016-00190
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2016,08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 404000-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2016
• Distributor Facility Aware Date: 08/03/2016
• Event Location: Home
• Date Report to Manufacturer: 10/25/2016
• Initial Date Manufacturer Received: 08/03/2016
• Initial Date FDA Received: 08/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/25/2016; 11/23/2016
• 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 Weight: 181