MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; VENTED HOSPITAL NASAL MASK

Model Number	RT042
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Section g4 and h4: device 1: lot#: 2102791658; date of manufacturing; 19 september 2023; udi: (b)(4).Device 2: lot#: 2102017384; date of manufacturing; 04 february 2022; udi: (b)(4).Device 3: lot#: 2102650880; date of manufacturing; 13 june 2023; udi: (b)(4).Section h10: the subject rt042 vented hospital nasal masks have been requested to be returned to f&p healthcare new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in illinois reported via a fisher and paykel (f&p) healthcare field representative that the seal of three rt042 vented hospital nasal masks were detaching from the mask frame.The healthcare facility has also indicated there were other rt042 vented hospital nasal masks from the same batch numbers with the same issue however this is still to be confirmed.There were no patient consequences reported.
Event or Problem Description
A healthcare facility in illinois reported via a fisher and paykel (f&p) healthcare field representative that the seal of three rt042 vented hospital nasal masks were detaching from the mask frame.The healthcare facility has also indicated there were other rt042 vented hospital nasal masks with the same issue, however, the quantity could not be confirmed.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Corrected data: section d1: brand name updated to fisher & paykel healthcare.Section d2: common device name updated to vented hospital nasal mask.Section d2a: product code updated to byg.Section g1: manufacturer contact office: contact person changed to mr.(b)(4).Section g4: no 510(k) number was included in section g4 of the report because the device is a class 1 device and exempt from pma pathway to regulatory approval.Section d4 and h4: device 1: lot#: 2102791658; date of manufacturing; 19 september 2023; udi: (b)(4).Device 2: lot#: 2102017384; date of manufacturing; 04 february 2022; udi: (b)(4).Device 3: lot#: 2102650880; date of manufacturing; 13 june 2023; udi: (b)(4).Section h11: method: the subject rt042 vented hospital nasal masks were returned to f&p healthcare for evaluation, where they were visually inspected.Results: visual inspection of the returned masks confirmed that the facial seal was fully separated from the mask base on all three devices.Conclusion: we were unable to determine the root cause of the observed separation as there is no evidence of incorrect manufacturing of the masks.The rt042 vented hospital nasal mask has a hard plastic base, with foam cushion and nasal seal around the outer edge of the base to seal onto the patient.The nasal seal is inserted onto the base of the mask until it is aligned.To remove a properly fitted seal requires excessive force.The user instructions illustrate in pictorial format the correct set-up and proper use of the rt042 vented hospital nasal 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.".

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: VENTED HOSPITAL NASAL MASK
• 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: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 18628620
• Report Number: 9611451-2024-00064
• Device Sequence Number: 16906271
• Product Code: BYG
• UDI-Device Identifier: 09420012430236
• UDI-Public: (01)09420012430236(10)2102791658(11)230919
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K017276
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024
• 2 Devices were Involved in the Event: 1 2

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: RT042
• Device Catalogue Number: RT042
• Device Lot Number: SEE H11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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