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

Model Number CG9701

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Per the dealer, the pump is weak and is not pushing out strong enough air pressure to fill the mattress.

• 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
• Manufacturer (Section G): GRAND HEALTHCARE CO., LTD.; 4f, no. 49, sec.2; jen ai road; taipei ; TW
• Manufacturer Contact: gregory stevens ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 3973249
• MDR Text Key: 4634009
• Report Number: 1531186-2014-02807
• 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: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/24/2014,06/23/2014

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: 07/24/2014
• Distributor Facility Aware Date: 06/23/2014
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 07/24/2014
• Initial Date Manufacturer Received: 06/23/2014
• Initial Date FDA Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other