MAUDE Adverse Event Report: INVACARE FLORIDA VC5310 VALUECARE BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number VC5310

Device Problem Crack (1135)

Patient Problems Bacterial Infection (1735); Laceration(s) (1946)

Event Date 04/02/2018

Event Type  Injury  

Manufacturer Narrative

The dealer stated that the bed is a medicare rental that had no previous issues.She was not aware of how the foot board became cracked or how long it had been cracked before the patient contacted her.The dealer serviced the bed by replacing the foot end, and she disposed of the damaged foot end prior to contacting invacare.Therefore, the product is not available to be returned for an evaluation, and the reported issue cannot be confirmed.It is not likely that the crack in the foot board was a result of a device malfunction but rather was due to physical damage.The plastic bed end cover is not designed to withstand excessive force.Based on the information provided, that the patient was pushing against the foot board to reposition herself in the bed when the injury occurred, it is likely that she had performed this action previously, causing the crack in the foot board.Should additional information become available, a supplemental record will be filed.

Event Description

The dealer reported that the patient was repositioning herself by pushing her feet against the plastic portion of the foot bed end on the vc5310 bed, and the plastic was cracked, which caused her to sustain a cut to one of her toes.Ten days later, the patient went to the hospital where it was discovered that she had a mrsa infection.The patient was admitted to the hospital for antibiotic treatment, and skin tissue was removed from her toe due to the infection.

• Brand Name: VC5310 VALUECARE BED
• 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: 7597483
• MDR Text Key: 110934819
• Report Number: 1031452-2018-00008
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VC5310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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: 67 YR
• Patient Weight: 79