MAUDE Adverse Event Report: SICHUAN AST MEDICAL EQUIPMENT CO., DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL

Model Number	700-959
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Abrasion (1689); Bruise/Contusion (1754); Myocardial Infarction (1969)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) healthcare was notified of an incident involving a rollator by the end user who stated the front legs fold in on themselves and caused him to fall several times resulting in multiple scrapes, bruises and cuts to his body and face.The end user reported that his doctor informed him that he had a heart attack after one of his falls.The end user did not identify how or why the issue was occurring.The injuries have not been specified to date.As part of its complaint review and evaluation process, (b)(6) healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): SICHUAN AST MEDICAL EQUIPMENT CO.,; no.58, jin-peng road, c area,; luxian industrial park luzhou,, sichuan 64610 0; CH 646100
• MDR Report Key: 19523312
• Report Number: 2438477-2024-00029
• Device Sequence Number: 12864885
• Product Code: ITJ
• UDI-Device Identifier: 00754021210886
• UDI-Public: 00754021210886
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 06/12/2024
• Report Date (Section F): 06/12/2024

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: 700-959
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/06/2024
• Event Location: Home
• Date Report to Manufacturer: 06/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2024
• 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: Other
• Patient Age: 55 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/12/2024