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

Model Number CG9701

Device Problem Improper Flow or Infusion (2954)

Patient Problem Ulceration (2116)

Event Type  Injury  

Event Description

Caregiver stated that the cg9701 alternating pressure pad and pump is not working properly.Caregiver stated that some of the cells are not inflating after they deflate during alternating.Multiple leaks in the pad have been repaired.Caregiver stated that the end user had bed sores before using the pad and some have gone away but came back, the alternating feature not working on the bed is not helping them to heal.Caregiver states the patient has been receiving medical attention for wounds.

• 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: 4505780
• MDR Text Key: 5487876
• Report Number: 1531186-2015-00917
• 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: 02/10/2015,02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2015
• Distributor Facility Aware Date: 02/05/2015
• Device Age: 2 YR
• Date Report to Manufacturer: 02/10/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention