MAUDE Adverse Event Report: INVAMEX IVC FULL ELECTRIC LOW BED; AC POWERED BED

Model Number	NA:5410LOW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Physical Entrapment (2327)
Date of Event	06/09/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The facility (b)(6) reported an entrapment incident that led to a patient's death.The event involves the ivc 5410low electric bed, manufactured by invacare sanford (florida) on may 1, 2022.The half rails and mattress used at the time of the incident were unknown.The facility was unable to provide further information regarding the manufacturer and or serial number or date code for these accessories.There was no malfunction or issue alleged with the bed or half rails.The facility has removed from bed from use.The patient had multiple pre-existing medical conditions documented in this report that may have contributed to this incident.Bed rail entrapment is a known risk in the use of bed¿s equipped with bed rails.The bed rail entrapment risk notification guide provided with the bed advises, ¿proper patient assessment, equipment selection, frequent patient monitoring, and compliance with instructions, warnings and this bed rail entrapment risk notification guide is essential to reduce the risk of entrapment.Only the patient¿s medical care provider and/or the dealer from whom you obtained this equipment, upon proper assessment of the patient¿s medical condition and needs, can evaluate whether this equipment is appropriate for use by any particular patient and assist the patient, the patient¿s family and/or the patient¿s primary day-to-day caregiver in assessing the risk of entrapment.¿ should any additional information become available, a follow up report will be filed.Note: the manufacturer of the subject bed is invacare sanford (florida) which is no longer in operation.This device is now manufactured at the invacare invamex location in mexico; therefore, the invamex address and cfn number is being utilized for the mdr filing.
Event or Problem Description
Per fda medwatch form, an 80 year old male weighing 196lbs was found deceased and lying on the floor, with his arm caught in the bed rail.The patient's head was on the floor with his lower body suspended in the air.
Event or Problem Description
Per fda medwatch form, an 80 year old male weighing 196lbs was found deceased and lying on the floor, with his arm caught in the bed rail.The patient's head was on the floor with his lower body suspended in the air.
Additional Manufacturer Narrative
This follow up medwatch is being submitted per a request by the fda to include the missing related report numbers from h10 of the initial medwatch submitted on 7/30/25.The facility filled out two reports, one for each component of the bed involved, for this event.There was only one adverse event regarding the 5410low bed.

• Brand Name: IVC FULL ELECTRIC LOW BED
• Common Device Name: AC POWERED BED
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamauilipas
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamauilipas
• Manufacturer Contact: mike simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 22667167
• Report Number: 9616091-2025-00012
• Device Sequence Number: 20693034
• Product Code: FNL
• UDI-Device Identifier: 00841447102168
• UDI-Public: 00841447102168
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: NA:5410LOW
• Device Catalogue Number: 5410LOW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 89 KG