MAUDE Adverse Event Report: EEZCARE MEDICAL CORP DRIVE; MATTRESS

Model Number 14030XP

Device Problem Inflation Problem (1310)

Patient Problems Bruise/Contusion (1754); Head Injury (1879)

Event Date 10/28/2022

Event Type  Injury  

Event 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
• Type of Device: MATTRESS
• Manufacturer (Section D): EEZCARE MEDICAL CORP; no. 3-1, minquan st; new taipei city, tucheng dist 23679 ; TW 23679
• MDR Report Key: 16112164
• MDR Text Key: 306795382
• Report Number: 2438477-2022-00131
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00822383111605
• UDI-Public: 822383111605
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 01/06/2023
• Distributor Facility Aware Date: 11/22/2022
• Date Report to Manufacturer: 01/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female