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

Model Number 5410IVC

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 01/03/2022

Event Type  Injury  

Event Description

The patient's son reported that due to a previous stroke and other health issues, his father has difficulty walking, and as he was getting out of the 5410ivc bed, he lost his balance and fell while holding the footboard.As he fell, his arm slid down the outside of the footboard to the gearbox, which the son claimed has a very sharp groove/opening that severely cut his father¿s arm, which resulted in hospitalization for several days.The patient's son advised that the patient has thin skin and is a fall risk, and he inquired as to whether there is a cover available to install over the groove/opening of the gearbox to prevent an incident like this from happening again.

Manufacturer Narrative

There is a gearbox located on each bed end, which is part of the mechanism that raises/lowers the entire bed.There is an opening in the gearbox that allows for an emergency crank to be inserted onto the exposed shaft to manually lower the bed in the event of a power outage or an electronic malfunction.There is supposed to be a cover over the open shaft area, which can be flipped up when the crank needs to be utilized.A label on the gearbox warns, "close cover when not in use.Otherwise, damage or injury may occur." pictures of the bed end were provided, which show that the warning label is present on the gearboxes, but the cover is missing from one of the gearboxes.The patient's son stated that both gearboxes were covered upon delivery, and he is not sure what happened to the one cover since then.Pictures of the patient's injury were also provided, which show a skin tear that was more likely caused by forcefully sliding down the notched out area at the top of the gearbox housing rather than the larger open area at the bottom of the gearbox where the shaft is located.The patient's son also believes it was the notched out area at the top of the gearbox that his father caught his arm on, but they do not know for sure.At the time of the event, the bed was not being for its intended purpose, as a mattress support system that allows for articulation of the head and foot sections to provide different positions for the patient.The patient was attempting to use the bed to catch himself from falling.The claim that the gearbox housing is "sharp" has not been confirmed.Invacare previously conducted a sharps test per ul 1439, which is a standard for safety tests for sharpness of edges on equipment.This test procedure is used to determine the potential personal injury related to the sharpness of edges that are part of or associated with appliances and equipment.Areas of the bed system accessible to the patient or caregiver during normal operation were tested to verify that no sharp edges were present.The edge of the gearbox was one of the specific areas tested, and it was observed to be acceptable, even with the gearbox cover removed.Based on the information provided, a product malfunction has not been confirmed.The underlying cause of the missing gearbox cover is undetermined.It is also unclear whether the injury could have been prevented had the gearbox cover been in place, since that area may not have been what actually contributed to the injury.The customer is working with (b)(6) to cover the gearboxes as a precaution.(b)(6) is getting a custom made cover for both ends, and they are adding more padding around the bed as well, since the patient is a fall risk.

• Brand Name: INVACARE IVC FULL-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: 13423244
• MDR Text Key: 289339080
• Report Number: 1031452-2022-00005
• 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: 01/06/2022

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
• Device Catalogue Number: 5410IVC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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 Sex: Male