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

Model Number	RT041M
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 rt041m 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 france reported that the seal of a rt041m non-vented hospital full face mask disconnected from the mask frame.There was no reported patient consequence.Further information with regards to the reported event was requested from the healthcare facility.
Additional Manufacturer Narrative
(b)(4).The rt041m non-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 rt041m non-vented hospital full face mask was not returned to fisher & paykel healthcare for evaluation.Further information on the reported event and patient consequence was requested, however no response was provided.Our investigation is therefore based on the information provided by the customer and our knowledge of the product.Results: the healthcare facility reported that the seal of a rt041m non-vented hospital full face mask disconnected from the mask frame.Conclusion: the complaint device was requested for investigation, however it was not provided for analysis.Without the return of the complaint device, we are unable to determine the cause of the reported event.The rt041m 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 during the manufacturing process to ensure the products meet or exceed the required detachment force.Our user instructions illustrate in pictorial format the correct set-up and proper use of the rt041m 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 healthcare facility in france reported that the seal of a rt041m non-vented hospital full face mask disconnected from the mask frame.There was no reported patient consequence.Further information with regards to the reported event was requested from the healthcare facility.

• 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: 16989977
• Report Number: 9611451-2023-00485
• Device Sequence Number: 6164169
• Product Code: CBK
• UDI-Device Identifier: 09420012429865
• UDI-Public: (01)09420012429865(10)2101994222(11)220121
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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: RT041M
• Device Catalogue Number: RT041M
• Device Lot Number: 2101994222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SPONTANEOUS VENTILATION WITH PRESSURE SUPPORT.; SPONTANEOUS VENTILATION WITH PRESSURE SUPPORT.
• Patient Sex: Unknown