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

Model Number 5410IVC

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Physical Entrapment (2327); Injury (2348)

Event Date 10/16/2016

Event Type  Death  

Manufacturer Narrative

Initial reporter relates that the facility did not immediately report the incident to the rental agency so the bed was picked up placed back into service.Prior to being placed into service the bed was inspected and no malfunctions or issues were noted.It was noted that when the incident occurred there was a non-invacare mattress in use on the bed.The mattress was one of two possible low air loss mattresses made by the same manufacturer.One of the models has a height dimension shorter and one has a height dimension taller than the mattresses recommended to be used on this bed.Rma issued.Also the medwatch form submitted to fda by vitas states patient was found dead with head between bed side rail and mattress while (b)(4) incident form that was faxed to us states patient was found by the facility aid with patients head lodged in the bed side rail and the rest of her body on the floor.Neither party has confirmed which is true.Obituary states patient passed peacefully in her sleep.We have received a lot of different information and changed stories on this file and will continue to research and attempt to find the facts.Owner¿s manual: 1114836 rev g lists the following warnings and instructions: warning! risk of injury or damage.To avoid injury or damage from misuse: do not install the accessories without reading and understanding all of the instructions in the instruction sheet that accompanies them.Included in the list of accessories to be used with this bed were mattress models: 5180, 5184, 5185, 5185xl solace series, softform series, microair series, warnings regarding the use of other mattresses include: danger! risk of death, injury, or damage bed accessories designed by other manufacturers have not been tested by invacare.Use of non-invacare bed accessories may result in injury or death.Use only invacare rails, mattresses, bed extenders and other accessories with invacare bed products.Refer to the bed rail entrapment risk notification guide at www.Invacare.Com for additional safety information.Danger! risk of death, injury, or damage: patient entrapment from the use of bed side rails may cause injury or death.To avoid patient entrapment: the invacare mattress must fit firmly against the bed frame and bed side rails to prevent patient entrapment.Follow the manufacturer¿s instructions.Monitor patient frequently.Read and understand the user manual prior to using the invacare bed and bed rails.User manuals are available at www.Invacare.Com or your dealer.After any adjustments, repair or service and before use, make sure all attaching hardware is tightened securely.Mattress platform, bed ends, pendant, and accessories are applied parts.Warning! risk of injury or damage: to avoid injury or damage from misuse or entrapment: read and understand the instructions or label provided with mattress.If you do not understand the instructions or if instructions are missing, contact the mattress manufacturer.Danger! risk of injury or adverse health consequences fall hazard exists due to use of non-invacare mattresses.Non-invacare mattresses are potentially incompatible with invacare beds.To avoid injury, ensure that only invacare mattresses are used with invacare beds at all times.Danger! risk of death, injury, or damage: replacement mattresses and bed side rails with dimensions different from the original equipment supplied or specified by the bed frame manufacturer are not interchangeable.Variations in bed side rail design, width and thickness or firmness of the mattress could cause/contribute to entrapment.Safety 3.1 general guidelines: danger! risk of death, injury, or damage 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.Pediatric patients or patients with small body size may also have an increased risk of entrapment.Monitor patients with these conditions frequently.Place the mattress deck in the flat position when left unattended.Danger! risk of death, injury, or damage: to avoid entrapment, product damage, and/or personal injury: invacare recommends that the mattress be centered on the bed frame.Otherwise, individuals may become trapped between the bed rail and the bed frame.Always test to make sure that the side rails are properly and securely in place before using.Otherwise, injury or damage may occur.Danger! risk of death or injury: an increased risk of patient entrapment may occur over time due to mattress compression.Periodically monitor gaps between the bed, mattress, and/or bed rail.Where gaps occur, patient entrapment is possible and the mattress should be replaced.Danger! risk of death, injury, or damage: to avoid entrapment, product damage, and/or personal injury: when used with a manual/electric bed, the bed rails do not fall under any weight limitations.Bed rails can be deformed or broken if excessive side pressure is exerted on the bed rails.These bed rails are used for the purpose of preventing an individual from inadvertently rolling out of bed.The bed rails are not intended nor may be used for restraint purposes.If an individual is capable of injuring himself/herself, a physician or a healthcare professional should be consulted for alternative means of safe restraint.After raising/lowering the head/foot end of the electric bed, check the distance between the bottom of the bed rail and the mattress.If there is excessive distance between the bottom of the bed rail and the mattress in which individuals may become entangled, adjust the height of the bed rail (if applicable), or provide alternative means of patient protection.Do not use the side rails as push handles for moving the electric bed.Replacement mattresses and bed side rails with dimensions different from the original equipment supplied or specified by the bed frame manufacturer are not interchangeable.Variations in bed side rail design, width and thickness or firmness of the mattress could cause/contribute to entrapment.Danger! risk of death, injury, or damage: to avoid product damage and/or personal injury from fall or entrapment invacare recommends the use of mattress keepers.Danger! risk of injury or adverse health consequences: fall hazard exists due to incorrect installation of bed rails.To avoid injury, ensure that the invacare bed rails are installed correctly and securely attached to the bed while entering or exiting.Fall hazard exists due to use of non-invacare bed rails.Non-invacare bed rails are potentially incompatible with invacare beds.To avoid injury, ensure that only invacare bed rails are used with invacare beds at all times.Fall hazard exists due to use of non-invacare mattresses.Non-invacare mattresses are potentially incompatible with invacare beds.To avoid injury, ensure that only invacare mattresses are used with invacare beds at all times.Danger! risk of death, injury or damage: to avoid entrapment, damage, and/or personal injury: these bed rails are intended to prevent an individual from inadvertently rolling out of bed.Do not use for restraint purposes.Invacare recommends the use of two sets of half-length bed rails: one set at the head end of the bed, and one set at the foot end of the bed where permitted.Use only invacare rails with invacare products.Do not use the bed rails as push handles when moving the bed.Should additional information become available, a supplemental record will be filed.

Event Description

The patient was found by the facility aid on (b)(6) 2016, with "her head lodged in the bed side rail, and the rest of her body on the floor".Injuries alleged: patient expired.

Manufacturer Narrative

We received pictures of the bed, rails and serial number label from the provider.The pictures and serial number were of a 5410ivc, which is similar to the alleged 5410low having the same frame but has different bed ends.The pictures also show the providers own serial number for the bed, which is reflected on the original order and providers inspection documents.The bed still has not been returned at this time.Should additional information become available, a supplemental record will be filed.

Event Description

The patient was found by the facility aid on (b)(6) 2016, with "her head lodged in the bed side rail, and the rest of her body on the floor".Injuries alleged: patient expired.

Manufacturer Narrative

The foot section, head section, bed ends and rails were all returned.An expanded evaluation was completed and the complaint could not be confirmed for the bed causing entrapment.The bed was set up and functionally tested with no malfunctions.There were no defects with the half rail assemblies.However, it was observed that the half rails were mounted 4.5 inches further down the head section than specified in the installation instruction sheet.Also the end user was using a non-invacare low air loss mattress, which the owner's manual explicitly warns that accessories designed by other manufacturers have not been tested by invacare and are not recommended for use with invacare products.It is noted that the serial numbers on the returned bed sections do not match the numbers originally provided.Multiple attempts to verify the serial numbers have been unsuccessful.

Event Description

The patient was found by the facility aid on (b)(6) 2016, with "her head lodged in the bed side rail, and the rest of her body on the floor." injuries alleged: patient expired.

• 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: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 6113008
• MDR Text Key: 60356073
• Report Number: 1031452-2016-03645
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 Weight: 54