MAUDE Adverse Event Report: INVACARE FLORIDA INVACARE(R) IVC(TM) SERIES HOMECARE BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 5410IVC

Device Problem Off-Label Use (1494)

Patient Problem Fracture, Arm (2351)

Event Date 01/12/2017

Event Type  Injury  

Manufacturer Narrative

The social worker reported that the end user is severely handicapped, very combative, and restless, and the 6629 rail was just not the right rail for her needs.The reported information does not reasonably suggest that there was a device malfunction associated with the serious injury.The reduced gap full-length bed rail model no.6629 operating instructions state, ¿entrapment may occur.Proper patient assessment and monitoring, and proper maintenance and use of equipment is required to reduce the risk of entrapment.Variations in bed rail dimensions, and mattress thickness, size or density could increase the risk of entrapment.¿ additionally, the bed rail entrapment risk notification guide states, "proper patient assessment, equipment selection, frequent patient monitoring, and compliance with instructions, warnings and this bed rail entrapment risk notification guide is essential to reduce the risk of entrapment.Conditions such as restlessness, mental deterioration and dementia or seizure disorders (uncontrolled body movement), sleeping problems, and incontinence can significantly impact a patient's risk of entrapment." the social worker was unable to provide any further information concerning the event.It is unknown exactly where the end user's arm got stuck (i.E.Between the cross braces of the rail, under the rail, etc.), the position of the rails at the time of the event (fully raised, intermediate, or lowered), the position of the bed and head/foot sections (raised or lowered), or the type of mattress being used.As there was no reported product malfunction, the device was not returned for evaluation.The facility is working with the end user's family and doctors to get the proper medical equipment for her needs so that she does not injure herself.Should additional information become available, a supplemental record will be filed.

Event Description

A licensed clinical social worker reported that her client was injured by the 6629 bed rail.Her client got her arm stuck in the bed rail and moved so violently that she broke her humerus.

• Brand Name: INVACARE(R) IVC(TM) SERIES HOMECARE BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 6388591
• MDR Text Key: 69398931
• Report Number: 1031452-2017-00032
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5410IVC
• Device Catalogue Number: 5410IVC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2017
• 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): Required Intervention
• Patient Age: 19 YR