MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. MAXXAIR ETS

Model Number 310800

Device Problem Inflation Problem (1310)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Initially, we have been informed that a mattress does not inflate and customer is experiencing other problems with the bed.No more details were provided.The facility was also claiming that there was an injury reported to one of the staff using the bed, however no details were provided as well.Although a very limited information was available it was decided to report this complaint due to the caregiver outcome.

Manufacturer Narrative

(b)(4).When reviewing reportable events for the barimaxx beds and maxxair mattresses ranges, we were able to find a few complaints, related to the hazardous situations for the caregiver/operator of the device, being a result of various scenarios.There is no trend observed for reportable complaints for these devices.Unfortunately, without having a description of what had actually occurred and under which circumstances it took place, we are left to review the limited information received from the customer per our best efforts, and compare it to our product knowledge.Based on the information collected to date we have been able to establish that the facility's staff suffered an injury while using the bed.Despite our best efforts, we could not obtain more detailed information.Therefore the severity of the injury allegedly sustained by the caregiver, cannot be assessed.The products involved in the incident are part of the arjohuntleigh usa rental fleet - each device in this fleet is checked before being released for a rental period with the next customer.The devices must be in full working condition in order to pass the test and be cleared for dispatch.After the event, the claimed devices were inspected by an arjohuntleigh representative at the facility - no faults have been identified.After return of the units to the rental center the side rail rod was lubricated and missing screw was replaced, however without more information of what happened in the event we are not in the position to determine whether the identified issues are related to the investigated event or not.There is no obvious conclusion we can come to from looking at the repairs alone.They do not point to issues that would be likely to trigger events.It was also confirmed that both, bed and mattress, were delivered with suitable quick reference guides and that the customer who reported the failure is renting these devices frequently and over a time have received multiple trainings.According to the device labeling (#310612-ah rev.B for barimaxxii), the following information is provided to the user of the device: -precaution should be taken during patient transfer, including the locking of caster brakes and caster steering and deflation of surface.-extra care should be taken when moving patients to and from the bed to avoid strains.Make sure any care givers that will be assisting the patient to and from the bed are physically capable of doing so.Unfortunately, with limited information available we are not in the position to confirm what had actually occurred and if arjohuntleigh device was and in which way involved in the hazardous situation.Please note, that in this event, there was no reported serious injury.Nevertheless, as the circumstances under which the failure occurred are unknown and a more detailed description of what have occurred is not available, it has been decided to report this event in abundance of caution and in the vein of our policy of transparency.In summary, it is unknown if the device failed to meet its specification or if it was user for patient's diagnosis or treatment while the event occurred.Given the circumstances and the fact that this incident appears to be a remote one, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: MAXXAIR ETS
• Type of Device: MAXXAIR ETS
• 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 78219 ; 2103170412
• MDR Report Key: 5185114
• MDR Text Key: 29800555
• Report Number: 3007420694-2015-00204
• 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: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/28/2015,09/28/2015

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?: No
• Device Operator: No Information
• Device Model Number: 310800
• 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: 10/28/2015
• Distributor Facility Aware Date: 09/28/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2015
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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