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

Model Number	RT041L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint rt041l non-vented hospital full face mask is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A healthcare facility in colorado reported via a fisher and paykel healthcare (f&p) field representative, that the seal of a rt041l non-vented hospital full face mask disconnected from the mask frame.There was no patient involvement.
Event or Problem Description
A healthcare facility in colorado reported via a fisher and paykel healthcare (f&p) field representative, that the seal of a rt041l non-vented hospital full face mask disconnected from the mask frame.There was no patient involvement.
Additional Manufacturer Narrative
(b)(6).Method: the complaint (b)(4) 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 the mask was assembled and glued properly.This suggests that the separation occurred post production.The (b)(4) 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 (b)(4) 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: NON-VENTED HOSPITAL FULL FACE MASK
• Common Device Name: CBK
• 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: 16989974
• Report Number: 9611451-2023-00482
• Device Sequence Number: 17683108
• Product Code: CBK
• UDI-Device Identifier: 09420012429858
• UDI-Public: (01)09420012429858(10)2101960802(11)211217
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K083122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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: RT041L
• Device Catalogue Number: RT041L
• Device Lot Number: 2101960802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• 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