MAUDE Adverse Event Report: CARROLL HEALTHCARE ASSIST BED RAILS 9153642097; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number IHARRO

Device Problems Mechanical Problem (1384); Material Separation (1562)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 01/31/2015

Event Type  Injury  

Event Description

Facility reported that when the bed rail latches, on a carroll healthcare arro bed, were pulled into the up position, outward pressure causes it to disengage and fall into the down position.End user fell from the bed onto the floor causing injury.Initial report was no serious injury.On (b)(6) 2015, follow up diagnostic/ct scans revealed non displaced fracture of right distal most clavicle, fractures to the right second, third, fourth and fifth ribs without major displacement and comminuted un displaced fracture of the right femoral head.Ct scan of head/brain also indicated small areas of hemorrhage in the ventricles, bilateral occipital horns, left temporal horn.Client sent to (b)(6) hospital (trauma center) for evaluation/treatment.

Manufacturer Narrative

The facility, initial reporter, has also filed a report directly with the fda.(b)(4).

• Brand Name: ASSIST BED RAILS 9153642097
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CARROLL HEALTHCARE; 994 hargrieve rd; london, ontario N6E 1P5; CA N6E 1P5
• Manufacturer (Section G): CARROLL HEALTHCARE; 994 hargrieve rd; london, ontario N6E 1P5; CA N6E 1P5
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4549994
• MDR Text Key: 5523197
• Report Number: 3003433498-2015-00038
• 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: Health Professional
• Type of Report: Initial
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IHARRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2015
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 74
• Patient Weight: 66