MAUDE Adverse Event Report: INVACARE CORPORATION CS5 BED; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number IHCS5

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

The facility indicated that the affected spot on the bed was very small, and the patient has fragile, thinner skin which played a part in her injury and the need for staples.Photographs of the bed were provided.One of the images shows the elevating section mounting bracket, the part that allegedly contributed to the injury.From the image, it appears that there may be an uneven area on the outer edge of the bracket, but its level of sharpness cannot be determined.The underlying cause of the bracket damage is also unknown.It was requested that the part be returned to invacare for further evaluation, but the facility was unwilling to return the part.The dealer advised that they covered the part with foam to prevent any further injury, and the bed is still in use.The serial number of the bed was requested but not provided.Only a partial serial number was visible from the photographs.

Event Description

The dealer reported that a facility alleged that a user cut her leg on a piece of metal located where the ihcs5 bed folds in the middle.The user received staples in her leg as a result of the injury.

• Brand Name: CS5 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: 9586456
• MDR Text Key: 188199034
• Report Number: 1525712-2020-00002
• 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: 10/25/2018

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: IHCS5
• Device Catalogue Number: IHCS5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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): Required Intervention