MAUDE Adverse Event Report: GAYMAR INDUSTRIES, INC. AIRE SELECT DYNAMIC LOW-AIR-LOSS THERAPY WITH ALTERNATI; LOW AIR DOSE MATTRESS

Model Number ATC-80

Device Problem Insufficient Information (3190)

Patient Problems Cardiopulmonary Arrest (1765); Gangrene (1873); Hip Fracture (2349)

Event Date 06/07/2016

Event Type  Death  

Event Description

Patient was hospice patient with terminal agitation got out of bed and was observed on the floor.Patient was in significant pain and was sent to the er.Patient was found to have fractured hip.Family requested to forgo treatment and keep patient comfortable.Patient ceased to breathe on (b)(6) 2016.

• Brand Name: AIRE SELECT DYNAMIC LOW-AIR-LOSS THERAPY WITH ALTERNATI
• Type of Device: LOW AIR DOSE MATTRESS
• Manufacturer (Section D): GAYMAR INDUSTRIES, INC. ; 10 centre drive; orchard park NY 14127
• MDR Report Key: 5883766
• MDR Text Key: 52410971
• Report Number: 5883766
• Device Sequence Number: 1
• Product Code: FNM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/09/2016

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: Other
• Device Model Number: ATC-80
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2016
• Distributor Facility Aware Date: 06/07/2016
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/09/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other
• Patient Age: 86 YR
• Patient Weight: 86