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

Model Number	RT040M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china reported that the seal of a rt040m vented hospital full face mask disconnected from the mask frame during patient use.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt040m vented hospital full face mask was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is therefore based on the information and photograph provided by the customer and our knowledge of the product.Results: visual inspection of the photograph provided revealed that the seals were found partly separated from the mask bases.However, a continuous bead of glue around the mask seal on the part of the mask is visable on the photograph.The part of the seal that didn't separate from the base indicates that the seal was properly inserted.Conclusion: we were unable to determine the root cause of the observed separation.Visual inspection indicated that the masks were assembled and glued properly.This suggests that the separation occurred post production.The rt040m full face mask features a mask base, seal, and headgear.The mask seal is inserted into the mask base and is secured with glue.Each assembled mask seal is inspected to ensure it is correctly inserted and there are no unacceptable gaps between the seal and the base.Samples are taken and the mask seals are pulled apart after 24 hours to ensure they meet or exceed the required detachment force before the assembled product can be released.Our user instructions illustrate in pictorial format the correct set-up and proper use of the rt040m non-vented hospital full face mask.It also states the following: "operating pressure range: 5 - 25 cmh2o"."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 result in loss of therapy, serious injury or death." "in the case of therapy device failure, the use of this mask requires the same level of attention and assistance as in the use of a tracheal tube.".

• Brand Name: VENTED HOSPITAL FULL FACE MASK
• Common Device Name: 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: 17962505
• Report Number: 9611451-2023-00971
• Device Sequence Number: 6790658
• Product Code: MNT
• UDI-Device Identifier: 09420012429834
• UDI-Public: (01)09420012429834(10)2102354336(11)220919
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/25/2023

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
• Operator of Device: Health Professional
• Device Model Number: RT040M
• Device Catalogue Number: RT040M
• Device Lot Number: 2102354336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown