MAUDE Adverse Event Report: GRAND HEALTHCARE CO., LTD. CARE GUARD PUMP AND PAD 9153633206; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number CG9701

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The caller states that the device is bottoming out in the middle.On setting 7.

• Brand Name: CARE GUARD PUMP AND PAD 9153633206
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): GRAND HEALTHCARE CO., LTD.; 4f, no. 49, sec.2; jen ai road; taipei ; TW
• MDR Report Key: 4338768
• MDR Text Key: 19762704
• Report Number: 1531186-2014-06496
• 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: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 12/17/2014,11/26/2014

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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2014
• Distributor Facility Aware Date: 11/26/2014
• Device Age: 5 MO
• Date Report to Manufacturer: 12/17/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other