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

A resident at a facility cut themselves on a sharp end of the assist rail, was taken to a doctor to have the cut looked at and was released.The facility is unwilling to share any other information on what happened with the resident.It is unknown if the end caps were missing upon receipt of the bed unit or during use.The facility stated that the assist rails are moved from bed to bed, not necessarily applied to the bed that it was shipped with, they could not provide any information relating to the date code for the rails.It has been determined that should the malfunction recur, the device would be likely to cause or contribute to a death or serious injury.

Event Description

Dealer stated that a facility reported that the ihrailae-dlx assist rail on an ihsc900dlx bed was missing the end caps.A resident allegedly cut themselves on a sharp end of the bed rail.The resident was taken to a doctor to have the cut looked at and was released.

• 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 44036 ; 8003336900
• MDR Report Key: 6301126
• MDR Text Key: 66548734
• Report Number: 1031452-2017-00022
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/06/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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