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

Model Number	RT041
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
Event or Problem Description
A distributor reported on behalf of a healthcare facility in (b)(6) reported that the seal of ten rt041 full face masks disconnected from the mask frame.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).The complaint rt041 full face masks are currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.
Additional Manufacturer Narrative
(b)(4).Method: the complaint rt041 non-vented hospital full face masks were returned to fph in new zealand and were visually inspected.Results: visual inspection of the returned devices revealed that the seal were partly separated from the mask base.However, a continuous bead of glue were found around the masks seals.Further inspection revealed that the part of the seals that were not separated from the bases indicates that the seals had been properly inserted in the mask bases.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 rt041 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 rt041 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.".
Event or Problem Description
A distributor reported on behalf of a healthcare facility in colorado reported that the seal of ten rt041 full face masks disconnected from the mask frame.There was no reported patient involvement.

• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13794887
• Report Number: 9611451-2022-00199
• Device Sequence Number: 4722835
• Product Code: CBK
• UDI-Device Identifier: 09420012429858
• UDI-Public: (01)09420012429858(10)2101709894(11)210707
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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
• Operator of Device: Health Professional
• Device Model Number: RT041
• Device Catalogue Number: RT041
• Device Lot Number: 2101709894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• 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