MAUDE Adverse Event Report: Invamex G5510 BED FULL ELECTRIC; AC Powered Bed

Model Number	G5510
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Head Injury (1879); Hip Fracture (2349)
Date of Event	07/06/2026
Type of Reportable Event	Death
Event or Problem Description
The end user was in a g5510 bed, taking a nap, and didn't realize he had rolled over on the bed remote causing it to go up as far as it would go.When he put his foot down to answer the phone, he fell out of the bed head first.He shattered his pelvis and broke his hip.He pressed his life alert button and he was taken to the closest hospital.Due to his injuries, he was put in a nursing home under hospice and passed away.
Additional Manufacturer Narrative
The subject device was a g5510 full electric bed.The serial number could not be provided at the time of this report.The age and manufacturer of the bed is unknown.This model bed has been manufactured at the invacare sanford and invacare invamex locations.The invacare sanford location is no longer in operation.The g5510 bed is currently being manufactured at invamex, so their information and cfn number were used for this medwatch.A return of the bed was requested; however, after following up with the caller there has been no further response regarding the availability of the bed to be returned.No return is expected at this time.There was no malfunction of the bed alleged.It has been determined that this event was the unfortunate outcome of unintended use error when the user rolled over onto the bed pendant.The specification prints of both possible pendants for the bed were reviewed and confirmed the buttons are recessed to help prevent accidental activation of the bed's functions.The owner's manual for the g5510 includes the following warnings: risk of death, injury or damage - improper use of this product may cause injury or damage.To avoid unintentionally pressing the pendant buttons and causing injury or damage: - do not place pendant under or between objects.Should additional information become available, a supplemental record will be filed.

• Brand Name: G5510 BED FULL ELECTRIC
• Common Device Name: AC Powered Bed
• Manufacturer (Section D): Invamex; avenida el puente s/n; parque industrial el puente ma; reynosa, tamaulipas 88783 ; MX 88783
• Manufacturer (Section G): Invamex; avenida el puente s/n; parque industrial el puente ma; reynosa, tamaulipas 88783 ; MX 88783
• Manufacturer Contact: dona bhamra ; one invacare way; elyria, OH 44035 ; +1(800)333-6900
• MDR Report Key: 50098101
• Report Number: 9616091-2026-00006
• Device Sequence Number: 10368298
• Product Code: FNL
• UDI-Device Identifier: 00841447102694
• UDI-Public: 00841447102694
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: G5510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Male