MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS FULL ELECTRIC FOOT SPRING 9153638201; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 5410IVC

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); Injury (2348)

Event Date 05/06/2014

Event Type  Injury  

Manufacturer Narrative

Mdr is being submitted as a result of a retrospective complaint review.End user daughter called advised mother was getting out bed had a jerking motion and leaned back on the bed and bed moved and caused end user to fall on the floor.Care taker grabbed end user but still fell to the floor.End user has a gash on her right arm that is bleeding, scrap on her back that is not bleeding, a bump on head from hitting the rail.End user landed on her left hip that has a wound back.End user daughter advised contacted a couple of dealers who advised would get back with her.End user advised local provider advised could put a temporary locking caster on bed daughter did not advised if accepted or declined.End user daughter could not provide any further information.

Event Description

End user daughter called advised mother was getting out bed had a jerking motion and leaned back on the bed and bed moved and caused end user to fall on the floor.Care taker grabbed end user but still fell to the floor.End user has a gash on her right arm that is bleeding, scrap on her back that is not bleeding, a bump on head from hitting the rail.End user landed on her left hip that has a wound back.End user daughter advised contacted a couple of dealers who advised would get back with her.End user advised local provider advised could put a temporary locking caster on bed daughter did not advised if accepted or declined.End user daughter could not provide any further information.

• Brand Name: FULL ELECTRIC FOOT SPRING 9153638201
• 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: 5650767
• MDR Text Key: 45054433
• Report Number: 1031452-2016-02093
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/13/2014

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5410IVC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2014
• Initial Date FDA Received: 05/12/2016
• 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): Other
• Patient Age: 73
• Patient Weight: 100