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

Model Number 15005LP

Device Problem Collapse (1099)

Patient Problem Fall (1848)

Event Type  Death  

Event Description

Drive devilbiss healthcare was notified of an incident involving a bed by a hospice center who stated that "when the patient was transferred into the bed, the bed completely collapsed and was in four pieces and the patient had to be lifted and placed in a wheelchair until a new bed was delivered." there was no information provided regarding any specific defect in the unit, or whether the issue was related to the assembly of the bed.The patient reportedly died hours later, but there was no indication whether the death was related to the incident.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: 17260643
• MDR Text Key: 318437621
• Report Number: 2438477-2023-00081
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 15005LP
• 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
• Patient Outcome(s): Death