MAUDE Adverse Event Report: UNKNOWN ALTERNATING PRESSURE AIR FLOTATION MATTRESS; 880.5550

Model Number CG9701

Device Problem Inflation Problem (1310)

Patient Problem Ulceration (2116)

Event Type  No Answer Provided  

Event Description

End user stated that there is a hole in the cg9701 careguard alternating pressure pad, it will not inflate.Enduser has had issue with pressure sores and due to this issue, they are getting worse.

• Brand Name: ALTERNATING PRESSURE AIR FLOTATION MATTRESS
• Type of Device: 880.5550
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4003909
• MDR Text Key: 4775977
• Report Number: 1531186-2014-03155
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/11/2014,07/09/2014

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: Lay User/Patient
• Device Model Number: CG9701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2014
• Distributor Facility Aware Date: 07/09/2014
• Date Report to Manufacturer: 08/11/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69
• Patient Weight: 91