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

Model Number UNKNOWN

Device Problem Collapse (1099)

Patient Problem Bruise/Contusion (1754)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Reporter stated that the bed keeps collapsing to the floor.Reporter stated that it hits the floor but when you use the pendant it will come up and then it will collapse again.Reporter states she was telling them she needed a bariatric bed.Reporter states she doesn't get to use the bed much because she has been in and out of the hospital.Reporter stated she did have to go to the hospital before and that was because the foot collapsed.She states this happened over the summer.Reporter states her case worker made us aware and that is how she got her new bed.She states she hit her back on the railing and the paramedics had to get her off of the floor because she is a recent amputee.Reporter states the hospital did a mri on her back and it was bruised.Reporter states she had to stay for awhile because they had to replace the bed and she states she couldn't move for a couple of days.

• Brand Name: ASM, FOOT SECTION W/ MOTOR PACKAGE
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5309545
• MDR Text Key: 33833366
• Report Number: 1525712-2015-05803
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2015
• 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
• Patient Weight: 172