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

Model Number 5410LOW

Device Problems Improper or Incorrect Procedure or Method (2017); Component or Accessory Incompatibility (2897)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

There was no allegation of a malfunction with the invacare bed.The rail involved in the incident is model 15201bv, which is not an invacare product.Based on the information provided, the event most likely resulted from a failure to follow instructions by using a non-invacare accessory on the invacare bed and by using the bed rail to assist with a transfer into the bed.The 5410low bed user manual warns, "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." it goes on to say, "fall hazard exists due to use of non-invacare bed rails.Non-invacare bed rails are potentially incompatible with invacare beds.To avoid injury, ensure that only invacare bed rails are used with invacare beds at all times." additionally, "to avoid personal injury or damage from misuse: bed rail is not an assist rail for getting into or out of bed." the facility representative has been advised that non-invacare products/accessories should not be used with invacare beds.The dealer has retrieved the bed and rails, so they are no longer in use by the patient.

Event Description

A facility representative reported that as a patient was attempting to transfer into the 5410low bed, she grabbed the right side rail which became shaky.This allegedly caused the patient to lose her balance and fall.The patient sustained a fractured coccyx.She elected to receive no medical treatment.

• Brand Name: INVACARE FULL-ELECTRIC LOW HOMECARE BED
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 10967645
• MDR Text Key: 220192659
• Report Number: 1031452-2020-00050
• Device Sequence Number: 1
• Product Code: LLI
• 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: 11/10/2020

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
• Device Catalogue Number: 5410LOW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• 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): Other
• Patient Age: 79 YR