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

Model Number SOLO

Device Problem Component Missing (2306)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Type  Death  

Event Description

One of carroll health care beds, bed rail ends got lost, so the end steel bed rail is exposed.When a resident transfer was in motion, the power w/c moved forward and got a chunk of flesh out of his right leg, he lost a lot of blood, he was sent to the hospital and now he is dead.Additional information by consumer affairs: facility rep alleged end user was being transferred from his chair to bed by staff and he moved as they started to transfer him and his leg hit the rail causing a 3"x2"x 1" deep cut in his leg with severe bleeding.He then passed away from the loss of blood.

Manufacturer Narrative

(b)(4) 2015 - should additional information become available, a supplemental record will be filed.

• Brand Name: ASSIST BED RAILS 9153642097
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CARROLL HEALTHCARE; 994 hargrieve rd; london, on N6E 1P5; CA N6E 1P5
• Manufacturer (Section G): INVACARE; one invacare way; elyria OH 44035
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4898835
• MDR Text Key: 16956817
• Report Number: 3003433498-2015-00102
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SOLO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2015
• 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): Death