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

Model Number RT040

Device Problem Break (1069)

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

Event Date 09/05/2022

Event Type  malfunction  

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.Method: the complaint rt040 vented hospital full face mask was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photograph provided by the customer, and our knowledge of the product.Results: visual inspection of the provided photograph revealed that the headgear velcro was separated from the headgear.Conclusion: we were 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.".

Event Description

A distributor reported on behalf of a healthcare facility in china that the headgear strap of a rt040m vented hospital full face mask was broken.There was no patient involvement.

• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9194534000
• MDR Report Key: 15534507
• MDR Text Key: 301130789
• Report Number: 9611451-2022-00916
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 09420012429834
• UDI-Public: (01)09420012429834(10)2101199780(11)200714
• 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,Health Professional,User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/08/2022

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: RT040
• Device Catalogue Number: RT040
• Device Lot Number: 2101199780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2020
• 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