MAUDE Adverse Event Report: SPAN MEDICAL PRODUCTS CANADA ULC; BED

Lot Number W257480

Device Problems Improper or Incorrect Procedure or Method (2017); Misassembly by Users (3133)

Patient Problem Fall (1848)

Event Date 04/04/2022

Event Type  Injury  

Manufacturer Narrative

Hometown nursing center was contacted on 8/8/2022, 8/11/2022, 8/16/2022, and 8/17/2022 but did not respond.On 8/22/2022 christopher anderson, the facilities director for hometown nursing center indicated via email that the resident was found on the floor with the pivot assist rail dislodged.The nursing staff checked the resident for injuries, and it was determined that there were no injuries due to the fall.The return of the pivot assist rail has been initiated but the rails have not been returned at the time of this report.An initial investigation was conducted based on the photos provided by the facility.The spring latch shown in the photo positions the assembly at the correct distance from the mattress to meet entrapment guidelines.The spring latch appears to be in good working condition in the photo.The locking of this assembly comes from a threaded handle in the mounting frame.A photo was provided of the threaded locking handle, and it appears operational.Post-production risk management indicates that the likelihood of recurrence is remote.The installation instructions are very clear showing that the snap button must go into one of three holes in the mounting tube and the clamping handle must be tightened.The risk analysis addresses the potential risk for the locking mechanism to come loose with a clear warning in the installation instructions to "test the assist rail to ensure that it is properly secured before leaving the patient".No further action required.

Event Description

The patient was attempting to roll out of bed with the assistance of the pivot assist when it came out of the holder.The patient fell to the floor.

• Type of Device: BED
• Manufacturer (Section D): SPAN MEDICAL PRODUCTS CANADA ULC; 4658 ontario street; beamsville, ontario L0R 1 B4; CA L0R 1B4
• Manufacturer (Section G): SPAN MEDICAL PRODUCTS CANADA; 4658 ontario street; beamsville, ontario L0R 1 B4; CA L0R 1B4
• Manufacturer Contact: erika ramsbottom ; 70 commerce center; greenville, SC 29615 ; 8646786957
• MDR Report Key: 15347793
• MDR Text Key: 299160262
• Report Number: 8022290-2022-00003
• 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: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: W257480
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male