MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD. DRIVE; BATH CHAIR

Model Number	12202KD-4
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare received a complaint involving a bath chair from a healthcare provider, who stated that there had been "three falls with injury " in their hospital.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.
Event or Problem Description
Drive devilbiss healthcare received a complaint involving a bath chair from a healthcare provider, who stated that there had been "three falls with injury " in their hospital.Upon investigation, it was revealed that the first incident was not a fall and did not involve an injury; the second incident was not a fall and did not involve an injury, but rather a report that a chair "tipped to the left" while a patient was leaning to the left side; and the third incident involved a patient who "leaned over too far" and fell, sustaining a laceration to her lip." all three chairs were confirmed discarded, so drive cannot retrieve them for evaluation.

• Brand Name: DRIVE
• Common Device Name: BATH CHAIR
• Manufacturer (Section D): BLISS HEALTH PRODUCTS CO., LTD.; no.61 & no.96, zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 16640044
• Report Number: 2438477-2023-00022
• Device Sequence Number: 17666672
• Product Code: ILS
• UDI-Device Identifier: 50822383222061
• UDI-Public: 50822383222061
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023
• Report Date (Section F): 04/12/2023

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: 12202KD-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 04/12/2023
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/12/2023