MAUDE Adverse Event Report: CARROLL HEALTHCARE RMA-MATTRESSES/BEDDING/OVERBED TABLES; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number NA:BEDPRD

Device Problem Component Missing (2306)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned and no return is expected.The bed rails are currently still in use.Maintenance has been completed on the rails, by the facility, to replace the plug buttons.Attempts to get additional information from the dealer on which cs bed models were involved, the number of rails and the date codes of the rails affected were unsuccessful.The dealer did state that the rails vary from 3 to 10 years old.The dealer reported no medical intervention was reported for the alleged scratches and minor cuts.Dealer will not provide any further end user information due to hipaa.Should additional information become available, a supplemental record will be filed.

Event Description

Dealer alleges the plug buttons are falling off the ihcsrlas bed rails, and the patients are cutting themselves.

• Brand Name: RMA-MATTRESSES/BEDDING/OVERBED TABLES
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CARROLL HEALTHCARE; 994 hargrieve rd; london, ontario N6E 1 P5; CA N6E 1P5
• Manufacturer (Section G): CARROLL HEALTHCARE; 994 hargrieve rd; london, ontario N6E 1 P5; CA N6E 1P5
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 6540453
• MDR Text Key: 74316637
• Report Number: 3003433498-2017-00001
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/03/2017

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: Health Professional
• Device Model Number: NA:BEDPRD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2017
• Initial Date FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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