MAUDE Adverse Event Report: INVACARE FLORIDA SEMI-ELEC SNGLE CRANK HI/LO 9153638224; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 5310IVC

Device Problem Collapse (1099)

Patient Problems Fall (1848); Impaired Healing (2378)

Event Date 12/22/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2017, the patient underwent a total right knee replacement.The alleged incident occurred on (b)(6) 2017, the patient's first morning awaking in the bed.The bed was a rental and was manufactured in june 2007, making it 9.5 years old at the time of the event.Prior maintenance and repair history of the bed is unknown, as well as the number of prior users.It is also unknown if the bed was evaluated by the provider following the incident or what, if any, malfunction of the bed was confirmed.The bed was not returned to invacare for evaluation; its current location is unknown.With the information provided, the underlying cause for the incident cannot be determined.Specific details regarding the patient's injury and subsequent treatment were not provided.Additional information has been requested from the patient¿s attorney; however, at this time no further details have been received.

Event Description

The patient¿s attorney reported that when the patient attempted to get up from the bed, the headboard allegedly collapsed, causing the patient to fall down onto the knee she just recently had surgery on.Paramedics were called to take the patient to the hospital where she was admitted to the emergency room.The patient was then transferred to a skilled nursing facility where she stayed for 6 days.

Manufacturer Narrative

Invacare's lawyer obtained photographs of the bed that was reportedly involved in the subject incident.Through a review of the photographs, no defects were noted with the device.It appears that the bed was simply not assembled correctly.The photographs show that the corner plate rivets on the right side of the head section are not seated in the corner lock on the right side of the bed end, which allows the bed to lean slightly to that side.Additionally, the drive shaft is detached from the gearbox output shaft on the head end of the bed.However, the photographs also demonstrate that the corner rivets are able to be properly seated in the corner lock as intended, which then allows the drive shaft to be reattached to the gearbox.The ivc bed series owner's manual provides detailed instructions/illustrations for assembling the bed, including assembling the bed ends by inserting the rivets on the corner plates of the spring section into the corner locks on the bed end until they lock in place.The bed was assembled by the dealer or a third party hired by the dealer.The bed has since been removed from the patient's home, and its current location is unknown.

• Brand Name: SEMI-ELEC SNGLE CRANK HI/LO 9153638224
• 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: 7127314
• MDR Text Key: 95158539
• Report Number: 1031452-2017-00062
• 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: Attorney
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2007
• 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
• Patient Age: 63 YR