MAUDE Adverse Event Report: INVACARE FLORIDA SC900DLX; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number NA:IHSC900DLX

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Abrasion (1689)

Event Type  malfunction  

Manufacturer Narrative

The facility maintenance representative advised that the issue was discovered when they were performing an inspection of all rails at the facility.It was observed that a total of 74 pairs of rails had at least one missing end cap.It is unknown at what point they went missing.The maintenance rep advised that the facility has a rail maintenance program to inspect the rails, but he was not aware of the last time it was completed.He stated that the residents are still using the rails with the missing end caps.He was aware that they shouldn't be using them, but he indicated that they had no choice.No injury or damage was reported as a result of the missing end caps.The date code of the rails is unknown; however, the maintenance rep advised that they are approximately 3 years old.He was unable to provide any further information regarding the rails.The underlying cause of the end caps falling out is undetermined.This issue has been previously investigated.The following statement was added to the ihrailae-dlx installation user manual: "to avoid death, injury or damage due to improper maintenance or inspection.Always maintain and inspect equipment per the instructions in this manual.Contact a qualified technician or invacare if any of the following issues are present: loose or missing parts such as end caps, knobs, bolts, screws etc., should be secured or replaced.Sharp edges or surfaces should be corrected or replaced." a design change has since been made to these assist rails, as of 10/26/2017.The plastic end cap has been replaced with a permanent steel cover, which is brazed onto the tube ends and buffed to create a smooth edge.Should additional information become available, a supplemental record will be filed.

Event Description

A maintenance representative from a facility reported that a resident was in bed and rubbed against the ihrailae-dlx assist rail while it was in the upright position and caused a surface scratch, due to the end caps had fallen out.The rails are being used on ihsc900dlx beds.No medical attention was sought.

• Brand Name: SC900DLX
• 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 44036 ; 8003336900
• MDR Report Key: 9364376
• MDR Text Key: 207569002
• Report Number: 1031452-2019-00093
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA:IHSC900DLX
• Device Catalogue Number: IHSC900DLX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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