MAUDE Adverse Event Report: INVACARE CORPORATION CS7 BED; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number IHCS7

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

The provider advised that the bed is inspected prior to use by each new patient.He stated that they didn't notice that the end plug was missing until after the injury occurred.The provider is not returning the rail to invacare.He advised that there is nothing wrong with the rail; the cap just fell out.He stated that they are ordering replacement caps for the rail to correct the issue.The underlying cause of the cap falling out of the rail is undetermined.This failure mode was previously investigated, and as a preventative action, the following statement was added to the assist rail 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.The plastic end cap was replaced with a permanent steel cover, which is brazed onto the tube ends and buffed to create a smooth edge.

Event Description

A provider reported that an end plug fell out of the assist rail on a cs7 bed, and the patient cut their leg on the rail and required 3 or 4 stitches.

• Brand Name: CS7 BED
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): INVACARE CORPORATION; one invacare way; elyria OH 44035
• Manufacturer (Section G): INVACARE CORPORATION; one invacare way; elyria OH 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 10461298
• MDR Text Key: 204599714
• Report Number: 1525712-2020-00020
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/10/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IHCS7
• Device Catalogue Number: IHCS7
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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