MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ATMOSAIR 9000; IKY

Model Number KA9REVG3580

Device Problems Deflation Problem (1149); Unstable (1667)

Patient Problems Skin Discoloration (2074); Pressure Sores (2326)

Event Date 10/22/2014

Event Type  malfunction  

Event Description

Arjohuntleigh was informed by the customer that the demo atmosair 9000 mattress was not stable and deflated on one side resulting in the patient sliding to one side (up to the bed side rails).The caregivers have tried to stabilize and level the mattress by placing a cushion below the mattress, without success.After 3 days, the mattress has been removed because redness on the patient skin has been observed.Patient developed 3 pressure ulcers stage i: on 2 locations of the vertebral column and 1 at the sacrum area.The patient was moved from this mattress to a "bubble pad" to prevent further development of wounds and to reverse the process, which was perceived as an adequate measure.

Manufacturer Narrative

As of (b)(6) 2012, complaints related to this product are to be handled by arjohuntleigh, inc.Additional info will be provided upon conclusion of the investigation including actual device evaluation.

• Brand Name: ATMOSAIR 9000
• Type of Device: IKY
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore rd ste 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore rd ste 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore rd ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4474697
• MDR Text Key: 5399858
• Report Number: 3009988881-2015-00005
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/04/2014

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: Other
• Device Model Number: KA9REVG3580
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/04/2014
• Initial Date FDA Received: 11/24/2014
• 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 Age: 90 YR
• Patient Weight: 70