MAUDE Adverse Event Report: INVAMEX MANUFACTURING FULL-ELECTRIC 9153638225; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number	NA:5410IVC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Physical Entrapment (2327)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The serial number of the bed is reported to be either (b)(6); the manufacturing month code (e vs f) could not be verified from the product label.The facility stated that the model of the side rail is unknown; it is unconfirmed whether it is an invacare product.The facility stated that when the incident occurred, the rails were in a raised position, the foot section of the bed was flat, and the head section of the bed was elevated 20 degrees.The facility confirmed that there was no malfunction with the 5410ivc full electric bed or the bed rails.Since the fall was not witnessed, the underlying cause is not certain; however, the facility advised that the patient was completely flaccid on his left side due to a stroke, and they suspect this pre-existing medical condition was a contributing factor.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 subject bed was manufactured by invacare florida (sanford); however, this manufacturing site is no longer in production.The manufacture of the 5410ivc bed has transitioned to invamex manufacturing (reynosa, mexico), so their cfn number is being utilized for the mdr filing.
Event or Problem Description
The dealer reported that a patient at a facility had an unwitnessed fall from a 5410ivc bed.It was reported that the patient tried to sit up & he fell headfirst from the bed.The patient was found by facility staff with his left arm stuck behind him between the rail & mattress, while his body was on the floor.The patient was sent to the hospital via ems where he received x-rays, and it was found that he had a fracture of the left distal humerus.The patient had surgery where he received placement of a plate and screw device with multiple screws transfixing the supracondylar fracture of the left humerus, and surgical skin staples were placed along the posterior aspect of the left elbow.

• Brand Name: FULL-ELECTRIC 9153638225
• Common Device Name: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): INVAMEX MANUFACTURING; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX MANUFACTURING; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: mike simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 21515420
• Report Number: 9616091-2025-00004
• Device Sequence Number: 4400287
• Product Code: LLI
• UDI-Device Identifier: 00841447102199
• UDI-Public: (01)00841447102199
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: NA:5410IVC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 03/04/2025
• Date Device Manufactured: 06/01/2005
• 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: Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 118 KG