MAUDE Adverse Event Report: SPAN MEDICAL PRODUCTS CANADA ULC MC7WML; ADVANTAGE READYWIDE

Model Number MC7WML

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 08/09/2022

Event Type  Injury  

Manufacturer Narrative

Advantage readywide beds are designed to meet entrapment guidelines per iec (b)(4).The product is certified by intertek and sgs, iecee approved cb testing laboratories.Patient entrapment warning labels are used on all beds.Entrapment hazards are explained in all use and care manuals.The bed was used in conjunction with a air fluidized therapy bed (drive air mattress ref 140274) which are exempt from entrapment reporting.No further action is required.

Event Description

The nurse found the resident sitting on the floor.When asked what happened, resident stated that he slipped from the bed.His right arm was caught in-between the side rail-end mattress.Resident denied hitting his head but complained of right shoulder pain.Staff assessed resident, no injuries seen at the time.

• Brand Name: MC7WML
• Type of Device: ADVANTAGE READYWIDE
• Manufacturer (Section D): SPAN MEDICAL PRODUCTS CANADA ULC; 4658 ontario street; beamsville, ontario L0R 1 B4; CA L0R 1B4
• MDR Report Key: 16230190
• MDR Text Key: 307976350
• Report Number: 8022290-2023-00001
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/23/2023

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?: No
• Device Model Number: MC7WML
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/28/2022
• Device Age: 4 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male