MAUDE Adverse Event Report: EEZCARE MEDICAL CORP DRIVE; MATTRESS

Model Number	14030XP
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Head Injury (1879)
Date of Event	10/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a pressure prevention mattress via medwatch report.The initial reporter stated that "his patient suffered bruising on her head from falling out of the mattress," reportedly because the "pump was not working, causing the mattress to deflate," "which then caused the patient to fall on the floor." the patient was reportedly admitted to the hospital and has been receiving therapy post-hospitalization.Drive obtained the unit for evaluation, during which it was determined that the pump operates as intended and fills bladder to full height.During evaluation, drive noted that the unit's emergency cord, used to deflate the unit immediately if cpr is necessary, was disconnected when received.If the emergency cord was disconnected during use, it would result in the complete deflation of the bladder.

• Brand Name: DRIVE
• Common Device Name: MATTRESS
• Manufacturer (Section D): EEZCARE MEDICAL CORP; no. 3-1, minquan st; new taipei city, tucheng dist 23679 ; TW 23679
• MDR Report Key: 16112164
• Report Number: 2438477-2022-00131
• Device Sequence Number: 20533622
• Product Code: FNM
• UDI-Device Identifier: 00822383111605
• UDI-Public: 822383111605
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2023
• Report Date (Section F): 01/06/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 14030XP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/22/2022
• Date Report to Manufacturer: 01/20/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Date Report Sent to FDA: 01/06/2023