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  

Event Description

Following information provided, the power cable of the maxxair ets pump was damaged with the sparks visible.There was no indication of the patient involvement.No injury was sustained.

Manufacturer Narrative

The process of gathering information is ongoing.The results of the analysis will be provided upon conclusions of the investigation.

Manufacturer Narrative

Following the information provided, the power cable of the maxxair ets pump was damaged with the sparks visible.There was no indication of patient involvement.No injury was sustained.The arjo representative visited the site, evaluated the bed and established that the mattress pump had a power cord torn from the pump.There were no smoke marks visible and no burning smell coming from the pump.Upon the service technician¿s assessment, the cord could be mechanically damaged by pulling or running over before transporting.This is in line with the power cord condition.The instructions for use for maxxair ets (document number: (b)(4)) include 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 damaging 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.The complaint was deemed reportable due to the allegation of sparks coming from the damaged power cord.No injury was sustained.

• 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: 16572346
• MDR Text Key: 311823384
• Report Number: 3007420694-2023-00055
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• 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: 02/22/2023
• 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