MAUDE Adverse Event Report: GRAND HEALTHCARE CO., LTD. ALTERNATING PRESSURE AIR FLOTATION MATTRESS; 880.5550

Model Number CG9702

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

The dealer states that they went out to set up this system yesterday and there was a leak coming from the mattress when they went to install it.

• Brand Name: ALTERNATING PRESSURE AIR FLOTATION MATTRESS
• Type of Device: 880.5550
• Manufacturer (Section D): GRAND HEALTHCARE CO., LTD.; 4f, no. 49, sec.2; jen ai road; taipei ; TW
• MDR Report Key: 4211621
• MDR Text Key: 5151314
• Report Number: 1531186-2014-05194
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/29/2014,10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CG9702
• 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: 10/29/2014
• Distributor Facility Aware Date: 10/09/2014
• Device Age: 2 YR
• Date Report to Manufacturer: 10/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other