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

Model Number NA:IHSC900DLX

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No return is expected for this product; therefore, the complaint of the assist rails missing their end caps could not be confirmed, and the underlying cause could not be determined.After speaking with the facility, it is unknown whether the end caps were missing upon receipt or if they fell off during use.It is unknown if the rails assembled to the bed were the rails originally provided in the bed package, as the facility was unable to provide the lot number of the rails and also stated that the rails are interchanged between beds within the facility.The ihrailae-dlx assist rail installation user manual states, "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." replacement assist rail plug kits were issued to the dealer for repair.

Event Description

Dealer stated that the assist rails were missing 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; sanford FL 32773
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 6301118
• MDR Text Key: 66548007
• Report Number: 1031452-2017-00021
• 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

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NA:IHSC900DLX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2017
• 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