MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ATMOSAIR 4000

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 11/23/2014

Event Type  No Answer Provided  

Event Description

On (b)(6) 2014, arjohuntleigh received a complaint related to deflating atmosair mattress.It was stated that when the patient was being turned by the staff, it was noted that the middle of the mattress appeared to be flat.The air cells appeared to have deflated.The patient was nursed on alternative sides during the night.Arjohuntleigh was contacted and patient was transferred to an alternative pressure redistribution system - auto logic.The patient developed a non blanching sacrum pressure ulcer stage 2.Ref mfr.# 3009988881-2015-00002.

• Brand Name: ATMOSAIR 4000
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 12625 wetmore road, ste 308; san antonio TX 78247 168
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 4390810
• MDR Text Key: 17281316
• Report Number: 1419652-2015-00013
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/03/2014

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other