MAUDE Adverse Event Report: INVACARE FLORIDA BED, SC900DLX FULL ELEC LOW HT WHITE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number IHSC900DLX

Device Problem Component Missing (2306)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Manufacturer Narrative

No return was issued for this product.The facility provided a photograph of the assist rail, which confirmed that the end caps are missing.However, the underlying cause could not be determined.It is unknown whether the end caps were missing upon receipt or if they fell off during use.The severity of the reported injury is unknown as well as whether or not any medical intervention was performed.Multiple attempts have been made to obtain further information without success.A capa was issued to address the missing end caps on the assist rails.As a preventative action, a statement was added to the bed rail manuals/instruction sheets to inspect for missing end caps, alerting users that they need to check for missing end caps and replace if needed.Replacement assist rail plug kits were issued to the dealer for repair.

Event Description

The facility reported that a resident was getting out of her wheelchair and into her bed when she got a 12" long gash on her foot from the ihrailae-dlx assist rails, which were missing their end caps.

• Brand Name: BED, SC900DLX FULL ELEC LOW HT WHITE
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: 6395275
• MDR Text Key: 69622722
• Report Number: 1031452-2017-00033
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IHSC900DLX
• Device Catalogue Number: IHSC900DLX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• 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