MAUDE Adverse Event Report: CARROLL HEALTHCARE ASM, FOOT SECTION W/ MOTOR PACKAGE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number IHCS7

Device Problems Collapse (1099); Component Falling (1105)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Customer alleges that the daughter of a resident was sitting with her mom in this bed that was in its highest position and the bed fell to the ground.The mom is ok but the daughter hurt her back and now filing a claim with the facility.The first thing the administrator checked was it if it was too much weight.The resident is under 100 lbs the daughter is under 200 lbs so they were not near the limit.No further details provided.Update from (b)(6) 2015: daughter stated she was sitting on the bed with her mom when all of the sudden it allegedly dropped to the ground and collapsed causing her neck pain.Her mom was ok.Daughter stated she went to her primary doctor for an x-ray of her neck and they ordered and mri to have her neck checked out further to see if there is a compression at her c7 disc.Bed has been replaced at facility and her mom is just in rehab there temporarily.No further information provided.

• Brand Name: ASM, FOOT SECTION W/ MOTOR PACKAGE
• 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: 5270099
• MDR Text Key: 32754412
• Report Number: 3003433498-2015-00179
• 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
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IHCS7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/07/2015
• 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