MAUDE Adverse Event Report: GRAND HEALTHCARE CO. LTD DRIVE DEVILBISS HEALTHCARE APP SYS,DLX,VARIABLE PRESSURE; COVER, MATTRESS (MEDICAL PURPOSES)

Model Number	14004E
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	12/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bariatric mattress.The end user reported that the mattress has failed on three occasions by "bottoming out," which resulted in the development of bed sores requiring home health wound care.Attempts to gather additional information have been unsuccessful.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.
Additional Manufacturer Narrative
Drive devilbiss healthcare received additional information indicating that the end user required prescription medication as part of their wound care management.During the review of mdr 2438477-2026-00001, it was identified that the manufacturer address documented in the report was incorrect.The correct manufacturer address is as follows: poliuretanos sa de cv alfredo nobel s/n zona industrial toluca, méxico 50010, mexico.Sections d3 and f14 of the mdr have been updated to reflect the accurate manufacturer address.
Additional Manufacturer Narrative
Drive devilbiss healthcare incorrectly reported the device as a bariatric mattress, product number 15301 and serial number (b)(6).The correct device is app sys, dlx,variable pressure, product number 14001e, serial number unknown.The device is not returning for evaluation.The end user has discarded the device.The correct manufacturer for product number 14001e is grand healthcare co.Ltd.4f, no.49, sec.2, jen ai road taipei, tw.This has been updated in section d1, d3,d4 and f14.

• Brand Name: DRIVE DEVILBISS HEALTHCARE APP SYS,DLX,VARIABLE PRESSURE
• Common Device Name: COVER, MATTRESS (MEDICAL PURPOSES)
• Manufacturer (Section D): GRAND HEALTHCARE CO. LTD; 4f, no. 49, sec. 2; jen ai road; new taipei, taipei 50010 ; TW 50010
• MDR Report Key: 24071244
• Report Number: 2438477-2026-00001
• Device Sequence Number: 15799661
• Product Code: FMW
• UDI-Device Identifier: 00822383534411
• UDI-Public: (01)00822383534411
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026
• Report Date (Section F): 04/03/2026

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: 14004E
• Device Catalogue Number: 14004E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/27/2026
• Event Location: Home
• Date Report to Manufacturer: 04/03/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 01/15/2026; 04/03/2026
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 159 KG
• Date Report Sent to FDA: 04/03/2026