MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. MAXXAIR ETS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 47129

Device Problem Sparking (2595)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.Conclusions will be provided within the follow-up report once the investigation is completed.

Event Description

Following the information provided there was an allegation of sparks emission from the maxxair ets system damaged power cord.No injury was sustained.The customer¿s representative placed a service call and required a replacement of the device.The nurse claimed that the cord kept sparking and leaving a burning smell near the outlet.The arjo representative visited the site, evaluated the pump and confirmed that it had a damaged power cord.The device was picked up.

Manufacturer Narrative

The information gathered in the course of the investigation indicate that the power cord could have been trapped under bed casters.The customer did not inform what were the circumstances of the cord damage, but upon the service technician¿s assessment, the cord may have been ¿run over causing a cut in the proactive casing¿.This is in line with the power cord condition, the insulation of the cord was cut, with scorched marks visible.The damage to the power cord insulation resulted in cable degradation, which could lead to alleged sparking.The instructions for use for maxxair ets (document number: 310115-ah) includes the following instructions related to the subject of the investigation: - ¿position power cord to avoid a tripping hazard and / or damage to the cord.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.¿ based on the above, the integrity of the cord insulation must first be compromised, prior to damage the cable this way resulting in sparking.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.

Event Description

Following the information provided there was an allegation of sparks emission from the maxxair ets damaged power cord.There was no patient involvement.No injury was sustained.The customer¿s representative placed a service call and required a bed replacement.The nurse claimed that the cord kept sparking and leaving a burning smell near the outlet.The arjo representative visited the site, evaluated the bed and established that the mattress pump had a damaged power cord.

• Brand Name: MAXXAIR ETS
• 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: 16173942
• MDR Text Key: 308165527
• Report Number: 3007420694-2023-00009
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 47129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2022
• 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