MAUDE Adverse Event Report: SHENYANG HENYI ENTERPRISE CO. DRIVE; LIFT, PATIENT, NON-AC-POWERED

Model Number 13023SV

Device Problem Mechanical Problem (1384)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 09/18/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a patient lift by the end user's son, who stated that the lift dropped down suddenly while in use and caught the end user's feet under the lift.The end user reportedly fractured his left foot and required stitches on his right foot.Drive made repeated attempts to gain additional information and have the product returned for inspection, but the complainants did not respond.If pertinent information becomes available to drive at a later date, an addendum to this report will be filed.

• Brand Name: DRIVE
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): SHENYANG HENYI ENTERPRISE CO.; no.386-3 qingnian st.; heping dist.; shenyang, liaoning 11000 4; CH 110004
• MDR Report Key: 18049222
• MDR Text Key: 327090111
• Report Number: 2438477-2023-00139
• Device Sequence Number: 1
• Product Code: FSA
• UDI-Device Identifier: 00822383135441
• UDI-Public: 822383135441
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 13023SV
• Device Catalogue Number: 13023SV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2023
• Distributor Facility Aware Date: 09/18/2023
• Event Location: Home
• Date Report to Manufacturer: 11/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female