MAUDE Adverse Event Report: M.C. HEALTHCARE PRODUCTS MAXXUM; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number QD8250

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Physical Entrapment (2327)

Event Date 04/21/2015

Event Type  Death  

Manufacturer Narrative

Trying to get product back.

Event Description

We received an e-mail on 2016/11/01 that showed a photo of our bed, maxxum, that was allegedly involved in an entrapment death occurring on (b)(6) 2015.The patient was found on the floor mat with the bed in the lowest position and wrapped in bedding.Her left cheek was on the mattress and the right side of her neck and chin just below her jawbone was positioned against the quarter rail.There was a bed sensor but it was covered in bedding.There is no known failure or deterioration in the effectiveness of the bed; however, the patient did become entrapped between the maxxum bed rail and an unknown mattress at entrapment zone 3/4.

• Brand Name: MAXXUM
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): M.C. HEALTHCARE PRODUCTS; 4658 ontario st.; beamsville, ontario L0R 1 B4; CA L0R 1B4
• Manufacturer (Section G): M.C. HEALTHCARE PRODUTS; 4658 ontario st.; beamsville, ontario L0R 1 B4; CA L0R 1B4
• Manufacturer Contact: william darby ; 70 commerce center; greenville, SC 29615 ; 8646786936
• MDR Report Key: 6103631
• MDR Text Key: 59967103
• Report Number: 1041130-2016-00001
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QD8250
• Device Catalogue Number: QD8250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/15/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 70