MAUDE Adverse Event Report: INVACARE FLORIDA IVC BARIATRIC BED 9153641598; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number BAR600IVC

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

Patient Problems Bruise/Contusion (1754); Laceration(s) (1946); Swelling (2091); Physical Entrapment (2327)

Event Type  Injury  

Manufacturer Narrative

The provider of the bed stated that he was not aware of how the patient got her leg stuck.He stated that he and the patient's case worker have been out to the patient's house several times and have confirmed that nothing is wrong with the bed.He and the case worker believe that the patient is unable to take care of herself and that she is in need of more care, like one would find in a facility.The bed is being used with bar6640ivc half-length rails and a barmatt42 mattress, both of which are approved accessories for the bar600ivc bed.The width of the bed frame and the mattress, as well as the distance between the rails, is 42 inches, thereby reducing any gap between the mattress and the bed rails.An increased risk of patient entrapment may occur over time due to mattress compression; however, the provider indicated that current mattress compression is minimal.The provider indicated that the patient's weight does fluctuate, at times exceeding (b)(6) pounds; however, the reported weight of the patient at the time of the event was (b)(6) pounds.The bar600ivc user manual warns, "patients that weigh less than (b)(6) pounds have an increased risk of entrapment.To avoid injury or damage from entrapment, patients that weigh less than (b)(6) pounds should not use the ivc bariatric bed." there was no reported product malfunction associated with the alleged injury; therefore, the device will not be returned for evaluation.Should additional information become available, a supplemental record will be filed.

Event Description

The patient reported that she was scooting down the bed to get out, instead of lowering the bed rail, and she rolled between the rail and the mattress.She indicated that she could not move, so she was stuck in that position overnight (zone 3 entrapment).She alleged that her stomach was bruised from being stuck in that position.The patient also alleged that her left leg was swollen before she got stuck, and it became more swollen while she was stuck, and the rail cut her left leg.She stated that medics came and had a hard time getting her out.She then indicated that she took herself to the hospital and was admitted for 5 days to treat her leg.

• Brand Name: IVC BARIATRIC BED 9153641598
• 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: 7052085
• MDR Text Key: 92721612
• Report Number: 1031452-2017-00059
• 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: Other
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BAR600IVC
• Device Catalogue Number: BAR600IVC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 147