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

Model Number 215200-R

Device Problem Inaccurate Information (4051)

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

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

Due to the damaged cable there was no power to the pump and therefore the mattress was not inflating.Moreover, the power cord cut could lead to sparks emission and alleged burning mark on the mattress.However, the presence of burning mark on the mattress was not confirmed by the service technician.The instructions for use for first step select therapy system (document number: 416001 rev.2) 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.¿ to conclude, the power cord was found to be damaged and from that perspective, the device did not meet performance specifications.The pump was in use by a patient when the issue occurred.No injury was reported.The complaint was assessed as reportable due to allegation about the burning mark on the mattress (which would indicate a presence of sparks).However, this was not confirmed by the technician, who did not notice burning marks.The date of event was estimated.

Event Description

Arjo became aware of the event involving first step select system.The customer alleged that the power cord failed - it burnt out, there were some burn marks on the mattress, and that the mattress was not inflating.The system was in use by the patient when the issue occurred.No injury was reported.The arjo service technician inspected the system and found that the pump¿s power cord was probably run over causing a cut.The customer¿s employee agreed with the technician¿s observation.No burn mark was found on the mattress or the pump.The customer allegation referring to burning marks were not confirmed.The involved system was swapped out.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18370679
• MDR Text Key: 331061886
• Report Number: 3005619970-2023-00031
• 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
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 215200-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Date Manufacturer Received: 11/22/2023
• 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