MAUDE Adverse Event Report: HSINER CO., LTD. DRIVEMEDICAL; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	100FDL
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735); Eye Infections (4466)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a full-face mask for a cpap or bipap by an end user, who reported that "at the ends of the velcro straps there is a sharp black tab that cut into my eyelid." the end user reported the mask straps caused styes, a bacterial infection, an abscess of the eyelid, and a hospital stay including three days of iv antibiotics.It is unclear whether the device has been preserved or can be returned for evaluation.Drive devilbiss is investigating the incident, and an update will be filed if additional information becomes available.

• Brand Name: DRIVEMEDICAL
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): HSINER CO., LTD.; 312, jhongshang rd.; shengang; taichung city, 429 ; TW 429
• MDR Report Key: 19055817
• Report Number: 2438477-2024-00017
• Device Sequence Number: 8120999
• Product Code: BZD
• UDI-Device Identifier: 00822383294315
• UDI-Public: 00822383294315
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2024
• Report Date (Section F): 04/05/2024

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: 100FDL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/12/2024
• Event Location: Other
• Date Report to Manufacturer: 04/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2024
• 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; Hospitalization
• Patient Sex: Male
• Date Report Sent to FDA: 04/05/2024