MAUDE Adverse Event Report: INVAMEX INVACARE® G-SERIES BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	G5510
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This medwatch is being filed in an abundance of caution.The subject bed, a g5510 full electric bed was manufactured by invacare, invamex.Additional information was received, and it was confirmed that the g5510 bed was assembled correctly.The mattress, however, that was being utilized was not an invacare mattress.The mattress was an xl twin that is 14 inches deep.The g5510 user manual advises that bed accessories designed by other manufacturers have not been tested by invacare.Use of non-invacare bed accessories may result in injury or death.Use only invacare rails, mattresses, bed extenders and other accessories with invacare bed products.There is no indication of a malfunction or deficiency of the invacare g5510 bed.The underlying cause of the alleged incident is likely the result of a non-invacare mattress being used with an invacare bed.The va is addressing the concern.A product return is not anticipated, and no further information is expected.If additional information is received, a follow-up will be filed.
Event or Problem Description
The end user stated he has a g5510 bed that is 84 inches long and the va gave him an 80 inches long mattress.He indicated his bed needs to be fixed to be made 80 inches long.He reported that his pillow falls in the gap between the headboard and the mattress.He stated this has hurt his neck and there was a fracture to his spine.He advised that he will be having a surgical procedure.

• Brand Name: INVACARE® G-SERIES BED
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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 ; 8003336900
• MDR Report Key: 24689516
• Report Number: 9616091-2026-00003
• Device Sequence Number: 9706580
• Product Code: FNL
• UDI-Device Identifier: 00841447102694
• UDI-Public: 00841447102694
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male