MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. FIRST STEP SELECT; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 215200

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The information collected is compiled and evaluated for root cause analysis.A supplemental will be submitted when the investigation is completed.

Event Description

Power cord was sparking because it was run over with the bed frame.The power cord was replaced.No injury.

Manufacturer Narrative

The power cord was damaged resulting in sparks.The damaged was a result of running over the power cord with the bed frame.The device was taken out of use and power cord replaced.There was no injury.The instructions for use for first step select therapy system (document number: (b)(4) rev 2 dated 01/2021) includes the following instructions related to the subject of the investigation: ¿ensure power cord is kept free from all pinch points and moving parts and is not trapped under casters.Improper handling of the power cord can cause damage to the cord, which may possibly produce risk of fire or electrical shock.¿ ¿inspect all components for visible damage.Verify basic functionality and inspect all hoses, cords and other components for visible damage.Discontinue use and immediately contact manufacturer if damage is observed.¿ arjo device failed to meet its performance specification since the power cord was damaged.There was no allegation of patient involvement when the event occurred.This complaint is deemed reportable due to allegation of power cord damage resulting in emission of sparks.

• Brand Name: FIRST STEP SELECT
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 19039383
• MDR Text Key: 339335620
• Report Number: 3005619970-2024-00007
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 215200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/30/2024
• 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): Other