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

Model Number	RT045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of healthcare facility in japan, via a fisher & paykel healthcare (f&p) field representative that the headgear strap of a rt045 non-vented hospital full face mask was broken during patient use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.There is indication from the customer that this may not be the only event associated with this failure mode.We are seeking further information from the customer to ascertain further details.
Additional Manufacturer Narrative
(b)(4).The rt045 non-vented hospital full face mask features a mask base, seal, and headgear.The mask is intended to enable noninvasive positive pressure ventilation (nppv) therapy (cpap or bi-level) to be delivered to spontaneously breathing adult patients with respiratory insufficiency or respiratory failure and have been prescribed nppv.The masks are to be fitted and therapy maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.Method: the subject rt045 non-vented hospital full face mask was returned to f&p healthcare in new zealand for evaluation where the unit was visually inspected.Results: the visual inspection confirmed that the headgear straps layers were found separated and the straps were detached from the headgear back.Conclusion: we were unable to determine the cause of the reported damage found to the rt045 mask.The rt045 non-vented hospital full face masks are visually inspected at the time of production, and those that fail are rejected.The subject full face mask would have met the required specifications at the time of production.The user instructions illustrate in pictorial format the correct set-up and proper use of the rt045 non-vented hospital full face mask.It also states the following: "inspect the mask for damage.Discard the mask if any parts are broken or if the seal is torn." "ensure adequate patient monitoring is in place." "verify that the therapy device, including alarms and safety systems, are functioning correctly prior to use." "the mask must be fitted and therapy established by an appropriately trained medical practitioner or care provider." "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.".
Event or Problem Description
A distributor reported on behalf of healthcare facility in (b)(6), via a fisher & paykel (f&p) healthcare field representative that the headgear strap of a rt045 non-vented hospital full face mask broke during patient use.There was no reported patient consequence.

• Brand Name: NON-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: 18127972
• Report Number: 9611451-2023-01067
• Device Sequence Number: 7753113
• Product Code: MNT
• UDI-Device Identifier: 09420012436139
• UDI-Public: (01)09420012436139(10)2102546319(11)230314
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170367
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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 Expiration Date: 03/14/2026
• Device Model Number: RT045
• Device Catalogue Number: RT045
• Device Lot Number: 2102546319
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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