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

Model Number 47129

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)

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

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.When the information is available and the investigation completed a follow-up report will be provided.

Event Description

The customer staff reported that the mattress was leaking air causing the patient to fall out of the bed.The technician who visited the customer to pick up the equipment stated that the mattress cover looked tore, as if the zipper was broken.This however, would not cause an alleged leak in the mattress.

Manufacturer Narrative

The system inspection (pump and mattress) did not reveal any discrepancies.Currently the data are analysis, when investigation conclusion is available the final repot will be submitted.

Manufacturer Narrative

The customer staff reported that the mattress was leaking air causing the patient to fall out of the bed and that the side rail was broken.The technician who visited the customer to pick up the equipment stated that the mattress cover looked tore, as if the zipper was broken.This, however, would not cause an alleged leak in the mattress.The bed and system (pump with mattress) were inspected when they returned to the service center and no defect was identified.The quality control was completed without issues detected.Arjo made attempts to contact the customer and gather additional details, however without success.No response was provided.Therefore without the additional details, the cause of the patient¿s fall from the mattress remains unknown.If additional information becomes available the complaint will be re-assess at that time.The device was used during the patient treatment when the event occurred (a fall from the mattress), however the failure was not confirmed, the device met its specification.

• 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: 16634507
• MDR Text Key: 312297057
• Report Number: 3007420694-2023-00064
• 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,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 47129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2023
• 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