MAUDE Adverse Event Report: AGILITI HEALTH - HAYS SW LOW BOY; ELECTRIC BED

Device Problem Unintended Movement (3026)

Patient Problem Fall (1848)

Event Date 12/14/2023

Event Type  malfunction  

Event Description

An agiliti employee received a call from a representative with mesa stating a patient fell from a sw low boy bed after it was placed in a low position and set in trendelenburg, during which the brakes disengaged.The patient required ems assistance to be repositioned back into the bed.Mesa has replaced the bed with the patient's prior hca bed.There were no injuries reported in this incident.This incident is being reported due to the bed operating outside of its specifications.

• Brand Name: SW LOW BOY
• Type of Device: ELECTRIC BED
• Manufacturer (Section D): AGILITI HEALTH - HAYS; 500 commerce pkwy; hays KS 67601
• Manufacturer (Section G): AGILITI HEALTH - HAYS; 500 commerce pkwy; hays KS 67061
• Manufacturer Contact: jorge castro ; 500 commerce pkwy; hays, KS 67601 ; 8008149389
• MDR Report Key: 18503373
• MDR Text Key: 332787095
• Report Number: 1931307-2024-70004
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1