MAUDE Adverse Event Report: INVACARE CORPERATION CS3 ELEC BED 8 - 26 IN; AC POWERED BED

Model Number NA:IHCS3

Device Problem Component Missing (2306)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Manufacturer Narrative

The facility stated the rails are in good condition and they just need the plug buttons.The facility will not be returning the rails.An invacare tech is working with them to get plug the buttons replaced.Additional information was requested about the patient and the injury but not provided due to hipaa.The owner's manual includes a warning to inspect the bed rails for missing plug buttons.These rails were manufactured prior to a change that implemented a permanent brazed and buffed smooth steel cover.

Event Description

When the patient was being taken out the bed, her left leg got cut on the edge of the assist rail due to the rail plugs had fallen out.She was taken to the hospital and required to have (5) stitches in her leg.

• Brand Name: CS3 ELEC BED 8 - 26 IN
• Type of Device: AC POWERED BED
• Manufacturer (Section D): INVACARE CORPERATION; one invacare way; elyria OH 44036
• Manufacturer (Section G): INVACARE CORPERATION; one invacare way; elyria OH 44036
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 7284099
• MDR Text Key: 100582758
• Report Number: 1525712-2018-00026
• Device Sequence Number: 1
• Product Code: FNL
• 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: Other
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: NA:IHCS3
• Device Catalogue Number: IHCS3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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 Age: 71 YR
• Patient Weight: 90