MAUDE Adverse Event Report: GRAND HEALTHCARE CO., LTD. MATTRESS COVER FOR MEDICAL PURPOSES; 880.6190

Model Number CG9701

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2014

Event Type  No Answer Provided  

Event Description

Dealer stated, the mattress will not inflate because the power unit will not power on causing the users bed sores to get worse.

• Brand Name: MATTRESS COVER FOR MEDICAL PURPOSES
• Type of Device: 880.6190
• Manufacturer (Section D): GRAND HEALTHCARE CO., LTD.; 4f, no. 49, sec.2; jen ai road; taipei ; TW
• MDR Report Key: 3834867
• MDR Text Key: 4501916
• Report Number: 1531186-2014-01982
• Device Sequence Number: 1
• Product Code: FMW
• 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: 05/27/2014,04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: Yes
• 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: 05/27/2014
• Distributor Facility Aware Date: 04/15/2014
• Date Report to Manufacturer: 05/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 85