MAUDE Adverse Event Report: INVAMEX INVACARE IVC FULL-ELECTRIC LOW HOMECARE BED; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number 5410LOW

Device Problem Use of Device Problem (1670)

Patient Problem Hip Fracture (2349)

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

There was no reported malfunction/deficiency with the bed, rails, or mattress.The models of the mattress and the side rails in use at the time of the incident are unknown.The facility did advise that the patient was using an alternating pressure mattress.When these types of mattresses compress, the space between the mattress and the bed rail may increase, which can increase the risk of entrapment.Additionally, some of the patient's preexisting medical conditions may increase the patient's risk of harm by using bed rails.The 5410low user manual includes fda's "a guide to bed safety bed rails in hospitals, nursing homes and home health care: the facts" which advises that patients who have problems with memory, sleeping, incontinence, pain, uncontrolled body movement, or who get out of bed and walk unsafely without assistance, must be carefully assessed for the best ways to keep them from harm.The guide provides potential benefits and potential risks of using bed rails.One of the identified risks is bodily injury when patients or part of their body are caught between rails or between the bed rails and mattress.The guide instructs that when bed rails are used, perform an on-going assessment of the patient¿s physical and mental status; closely monitor high-risk patients.Note: the subject bed was manufactured by invacare sanford; however, this manufacturing site is no longer in production.The manufacture of these beds has been transferred to invamex, so their cfn number is being utilized for the mdr filing.Should additional information become available, a supplemental record will be filed.

Event Description

A facility administrator advised that facility staff report the patient was restless through the night.The patient was in a 5410low bed with both legs through the side rails, then she pulled her legs back through the rails.When a health assistant went to bathe the patient, she noticed the patient's left leg was deformed above the knee.The patient was lying in bed calmly.A doctor was notified, and the patient was transferred to the er and hospitalized with a closed displaced comminuted fracture of shaft of left femur.The patient had surgery.

• Brand Name: INVACARE IVC FULL-ELECTRIC LOW HOMECARE BED
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: mike simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 19123807
• MDR Text Key: 340350186
• Report Number: 9616091-2024-00006
• Device Sequence Number: 1
• Product Code: LLI
• UDI-Device Identifier: 00841447102168
• UDI-Public: 00841447102168
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/17/2024

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 Operator: Lay User/Patient
• Device Model Number: 5410LOW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 59 KG