MAUDE Adverse Event Report: NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., L DRIVE; BED

Model Number 15216P

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Type  malfunction  

Event Description

Drive devilbiss healthcare was notified of an incident involving a bed by a hospice center who stated that the end user "fell due to a bed malfunction." there was no information provided regarding any specific defect in the unit, or whether the issue was related to the assembly of the bed.Drive is currently investigating the incident, including attempting to inspect the unit, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: BED
• Manufacturer (Section D): NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., L; no. 88, yangcheng road; wuyao town; rugao, jiangsu 22653 3; CH 226533
• MDR Report Key: 17263731
• MDR Text Key: 318649686
• Report Number: 2438477-2023-00090
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 15216P
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2023
• Distributor Facility Aware Date: 06/05/2023
• Device Age: 2 YR
• Date Report to Manufacturer: 07/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1