MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ATMOSAIR; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number ATMOSAIR 9000

Device Problems Filling Problem (1233); Kinked (1339); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/20/2017

Event Type  malfunction  

Event Description

Our mattresses are becoming compromised and are not holding up as they should.It was noticed that the 2 bladders would not fill when the line has become kinked.Manufacturer response for therapeutic mattress, atmosait 9000 (per site reporter): arjohuntleigh is sending in temporary replacement mattresses.

• Brand Name: ATMOSAIR
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 12625 wetmore rd.; ste. 308; san antonio TX 78247
• MDR Report Key: 6544635
• MDR Text Key: 74439121
• Report Number: 6544635
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2017,04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: ATMOSAIR 9000
• Device Catalogue Number: KA9SONB3584-LINET
• 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: 04/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1