MAUDE Adverse Event Report: APEX HEALTH CARE MFG., INC.D DRIVE; MATTRESS

Model Number GV34200

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  malfunction  

Event Description

Drive devilbiss healthcare was notified of a complaint regarding a pressure prevention mattress by a provider, who stated that the "mattress has caused discomfort and pain and leading to medication." the provider did not provide any additional details as to the nature of any specific product malfunction or injury.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: MATTRESS
• Manufacturer (Section D): APEX HEALTH CARE MFG., INC.D; no. 6, industrial 2nd road; tou chiao industrial park; min hsiung shiang, chiayi ; TW
• MDR Report Key: 17166894
• MDR Text Key: 317806923
• Report Number: 2438477-2023-00087
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00822383013794
• UDI-Public: 822383013794
• 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
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: GV34200
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/20/2023
• Distributor Facility Aware Date: 05/24/2023
• Device Age: 11 MO
• Date Report to Manufacturer: 06/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1