MAUDE Adverse Event Report: ARJOHUNTLEIGH MAXXAIR MATTRESS

Catalog Number 310800

Device Problems No Audible Alarm (1019); Inflation Problem (1310); Connection Problem (2900)

Patient Problems Pressure Sores (2326); Injury (2348)

Event Date 11/14/2016

Event Type  malfunction  

Event Description

Upon admission to the hospital of a long term paraplegic pt with multiple pre-existing severe pressure ulcers, a maxxair mattress was placed on barimaxx ii bed for treatment of the existing wounds and pressure ulcer prevention.The mattress was set up by a staff member by connecting the three hoses of the mattress to the barimaxx ii bed.The bed was set for q 30 minute rotations in addition to the initiation of other pressure ulcer preventative nursing interventions.Within 72 hours, a new area of deep tissue injury was identified on the pt's buttock.After investigation, some of the mattress baffled were found not to be inflating due to individual connections at the baffles not being connected/closed.The baffle connections are located out of view on the underside of the bed.The baffles are obscured from view by the opaque covering when the bed is in use.There is no visual or auditory alarm on the equipment to bring attention to this condition.The deep tissue injury had progressed to an unstageable pressure ulcer at the time of discharge.

• Brand Name: MAXXAIR MATTRESS
• Type of Device: MATTRESS
• Manufacturer (Section D): ARJOHUNTLEIGH; addison IL 60101
• MDR Report Key: 6157610
• MDR Text Key: 62153934
• Report Number: MW5066596
• Device Sequence Number: 1
• Product Code: FNM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: A BARIMAXX II BED, PRODUCT ID: 310400; THE MATTRESS WAS PLACED ON AND CONNECTED TO
• Patient Age: 60 YR
• Patient Weight: 56