MAUDE Adverse Event Report: NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO DRIVE DEVILBISS; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 15300LW

Device Problem Mechanical Problem (1384)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/22/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a bariatric bed by an end user who reported that the bed was not lowering to the floor and only going waist high.The end user further stated that while attempting to get up on the mattress, she backed up to the side of the bed and slipped, hitting her backside on the attached bedrail and fracturing her tailbone.The end user was prescribed pain medications.Drive devilbiss is currently investigating the incident.An update will be filed if additional information becomes available.

• Brand Name: DRIVE DEVILBISS
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO; 259 jiugan road; sijing, shanghai ; CH
• MDR Report Key: 18365977
• MDR Text Key: 331009026
• Report Number: 2438477-2023-00152
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00822383008578
• UDI-Public: 822383008578
• 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: 12/20/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 15300LW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2023
• Distributor Facility Aware Date: 11/29/2023
• Event Location: Home
• Date Report to Manufacturer: 12/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female