MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ATMOSAIR 4000

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetics concept inc from november 2012 until 2014.Complaints related to these products were handled by arjohuntleigh inc.Additional information will be provided upon conclusion of the investigation.

• Brand Name: ATMOSAIR 4000
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore rd ste 308; san antonio TX 78247 000
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore rd ste 308; san antonio TX 78247 000
• Manufacturer Contact: pamela wright ; 12625 wetmore rd ste 308; san antonio, TX 78247-0000 ; 2102787040
• MDR Report Key: 4390765
• MDR Text Key: 5362965
• Report Number: 3009988881-2015-00002
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Reuse
• Patient Sequence Number: 1