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

Model Number RT043S

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/24/2023

Event Type  malfunction  

Event Description

A healthcare facility in new zealand reported via a fisher and paykel healthcare (f&p) field representative, an issue on rt043s non vented hospital full face mask.During device evaluation at fisher & paykel healthcare (f&p) in new zealand, the seal of a rt043s non vented hospital full face mask was found disconnected from the mask frame.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint rt043s non vented hospital full face mask was returned to fph in new zealand where it was visually inspected.Results: visual inspection of the returned device revealed that the seal was found partly separated from the mask base.However, a continuous bead of glue around the mask seal on the part of the mask was found.Further inspection revealed marks from the base in the glue on the detached part of the seal indicate that it was correctly inserted.Conclusion: we were unable to determine the root cause of the observed separation.Visual inspection indicated that there is no evidence of incorrect manufacturing of the mask.Possibly related to the effects of transport, or storage on the strength of the glue holding the mask seal to the base.The rt043s non vented hospital 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 rt043s non vented hospital full face mask.It also states the following: "operating pressure range: 3 - 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: NON-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: 17680443
• MDR Text Key: 322617743
• Report Number: 9611451-2023-00829
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K060044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2023

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: RT043S
• Device Catalogue Number: RT043S
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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