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

Model Number UNKNOWN

Device Problems Bent (1059); Noise, Audible (3273)

Patient Problems Fall (1848); Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(6) states her bed is noisy and it tossed her out of the bed.She states she is using 2 mattresses.She states the bed threw her legs out the bed and she followed.She states there is no air in the mattress.She states that she has rails on her bed but she keeps both sides down because she couldn't get out the bed with them up and one side is bent.She states she isn't sure how it bent.(b)(6) states she was sore when that happened.She states she is so used to falling out the bed, the bed jars her she said.I asked her when she fell out of the bed and she stated awhile ago, i always fall out of the bed.She states she has had multiple knee replacement surgeries.I was able to get her daughter (b)(6) on the phone and the mattresses are from drive and there are no invacare labels on the bed.Her daughter did state she needed new mattresses and that's what was causing her the problems.I gave them a few service centers and made them aware they would have to see if they repair the type of products they have.Unaware if the bed is a invacare bed.

• 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: 5270340
• MDR Text Key: 33068659
• Report Number: 1525712-2015-05661
• 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: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: No
• 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: 12/01/2015
• 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