MAUDE Adverse Event Report: INVACARE FLORIDA INVACARE SEMI-ELECTRIC HOMECARE BED; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number 5310IVC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Physical Entrapment (2327)

Event Date 03/13/2017

Event Type  Death  

Manufacturer Narrative

Although it was alleged that the invacare bed and rails were involved in an entrapment incident that resulted in a patient's death, there was no allegation of any defect with these invacare products.The patient was a quadriplegic who had cerebral palsy and spasticity.His medical conditions may have put him at higher risk for entrapment.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." it was alleged that the bed rails had been improperly installed, with the foot end of the rail mounted to the head of the bed.It is unknown whether the installation error caused/contributed to the entrapment event.As this is a legal matter, and invacare was not named in the lawsuit, no further information was given.However, should additional information become available in the future, a supplemental record will be filed.

Event Description

The provider reported that they received a summons for a case involving rail entrapment on a 5310ivc bed, which allegedly resulted in the patient's death.The lawyers for the patient's family reported that the bed rails involved were model 6629, which are invacare full-length rails.

• Brand Name: INVACARE SEMI-ELECTRIC HOMECARE BED
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• 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: 8864948
• MDR Text Key: 153398934
• Report Number: 1031452-2019-00021
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/22/2019

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: 5310IVC
• Device Catalogue Number: 5310IVC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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): Death
• Patient Age: 22 YR