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

Model Number BED38LOW-1633

Device Problem Collapse (1099)

Patient Problems Death (1802); Fall (1848)

Event Date 10/13/2015

Event Type  Death  

Manufacturer Narrative

Vitas healthcare filed initial medwatch; #(b)(4).Should additional information become available a supplemental record will be filed.

Event Description

Unwitnessed fall from bed.The caregiver states that the patient leaned on the bedrail and that it collapsed causing the patient to fall to the floor.Patient was not breathing when 911 arrived, patient was taken to the hospital and pronounced dead.Update from (b)(6) 2015: it was reported that the end user had nurses in and out of the house around the clock and there were no complaints of the bed rails not working properly.When the dealer arrived to pick up the bed, the rail was missing and the side piece of the head board was removed.They had to look around the house and found the bed rail hidden behind the couch.Invacare has requested for the bed to be returned for inspection and it was reported that they are not allowed to release it.

Manufacturer Narrative

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

Event Description

Update from 10/26/2015: reporter alleged the end user (b)(6) was in the bed in his room.Reporter alleged the end users wife and daughter heard a loud crash and end user was found on the floor with the bed rail underneath him.Reporter alleged that as a result of complications from the alleged fall, end user allegedly suffered a head injury and a punctured lung and expired a few hours later.Unwitnessed fall from bed.The caregiver states that the patient leaned on the bedrail and that it collapsed causing the patient to fall to the floor.Patient was not breathing when 911 arrived, patient was taken to the hospital and pronounced dead.Update from 10/23/2015: it was reported that the end user had nurses in and out of the house around the clock and there were no complaints of the bed rails not working properly.When the dealer arrived to pick up the bed, the rail was missing and the side piece of the head board was removed.They had to look around the house and found the bed rail hidden behind the couch.Invacare has requested for the bed to be returned for inspection and it was reported that they are not allowed to release it.

• Brand Name: ASM, FOOT SECTION W/ MOTOR PACKAGE
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5176277
• MDR Text Key: 29205103
• Report Number: 1031452-2015-16418
• 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: health professional,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 10/26/2015

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: BED38LOW-1633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 10/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2015
• 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
• Patient Age: 68 YR
• Patient Weight: 64