MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD VENTED HOSPITAL FULL FACE MASK; MNT

Model Number RT040S

Device Problem Connection Problem (2900)

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

Event Date 07/02/2023

Event Type  malfunction  

Event Description

A healthcare facility in china reported that the elbow of a rt040s vented hospital full face mask disconnected from the mask during patient use.There was no patient consequence.

Manufacturer Narrative

(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in china reported that the elbow of a rt040s vented hospital full face mask disconnected from the mask during patient use.There was no patient consequence.

Manufacturer Narrative

(b)(4).The rt040 vented hospital full face mask features a mask base, seal, and headgear.The mask is an oronasal patient interface for use as an accessory to therapy devices providing non-invasive bi-level or continuous positive airway pressure support therapy.This mask is for spontaneously breathing adult patients with respiratory insufficiency or respiratory failure who are suitable for non-invasive positive pressure support therapy in a hospital or clinical setting.Results: the customer reported the elbow of a rt040s vented hospital full face mask disconnected from the mask after using for less than 24 hours.Conclusion: the complaint device was requested for investigation, however it was not provided for analysis.Without the return of the complaint device, we are unable to determine the cause of the reported event.Our user instructions illustrate in pictorial format the correct set-up and proper use of the rt040 vented hospital full face mask.It also states the following: - "verify that the therapy device, including alarms and safety systems, have been validated prior to use." - "this mask may only be used in a hospital or clinical setting where the patient is adequately monitored by trained medical staff.Failure to monitor the patient may results in loss of therapy, serious injury or death.".

• Brand Name: VENTED HOSPITAL FULL FACE MASK
• Type of Device: MNT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17447482
• MDR Text Key: 321441547
• Report Number: 9611451-2023-00702
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 09420012429841
• UDI-Public: (01)09420012429841(10)2102378470(11)221007
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

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: Health Professional
• Device Model Number: RT040S
• Device Catalogue Number: RT040S
• Device Lot Number: 2102378470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DRAGER CARINA VENTILATOR.
• Patient Age: 76 YR
• Patient Sex: Female