MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS SEMI ELECTRIC FOOT SPRING 9153638202; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number VC5310

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Swelling (2091); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.It was reported that there is an injury allegation of right arm cut and swelling.It was reported that there were no fractured/broken bones.To determine if there were any broken bones, it is most likely that radiology imaging may have been performed.On the harms and severity table, the use of radiology imaging is considered medical intervention with a score of 3; therefore the injury alleged is an fda reportable event.User¿s manual review (1134867 rev.D, page 17) inspect all bed components for damage or excessive wear.

Event Description

The consumers son states the motor fell off of the bed.The end users son states his mom bent over to pick up a pill bottle putting her arm between the head and the bottom of the frame, and alleged the head of the bed fell on his mother's arm and cut her right arm with swelling.The son took her to urgent care to check for broken bones but none were confirmed.Update from 01/12/2016 added by consumer affairs: end user stated mom was checked out and there were no broken bones and he is not aware of any additional medication prescribed for the incident.

• Brand Name: SEMI ELECTRIC FOOT SPRING 9153638202
• 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: 5366231
• MDR Text Key: 35962191
• Report Number: 1031452-2016-00142
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: VC5310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization