MAUDE Adverse Event Report: CARROLL HEALTHCARE ASSIST RAIL 9153650583; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number IHARRLAS

Device Problems Detachment Of Device Component (1104); Device Maintenance Issue (1379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Event Description

Maintenance director at the facility and he said that they have a lot of old beds with this same rail and they need caps for about 50 beds to do the proper maintenance on them.Customer alleged the end cap on the rails are off.

• Brand Name: ASSIST RAIL 9153650583
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CARROLL HEALTHCARE; 994 hargrieve rd; london, on N6E 1 P5; CA N6E 1P5
• Manufacturer (Section G): CARROLL HEALTHCARE; 994 hargrieve rd; london, on N6E 1 P5; CA N6E 1P5
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5662658
• MDR Text Key: 46108187
• Report Number: 3003433498-2016-00105
• 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: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IHARRLAS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2016
• 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