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

Model Number	RT046M
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan that the elbow of a rt046m non-vented hospital full face mask was leaking gas during patient use.There was no patient consequence reported.
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.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan that the elbow of a rt046m non-vented hospital full face mask was leaking gas during patient use.There was no patient consequence reported.
Additional Manufacturer Narrative
(b)(4).The rt046 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 complaint rt046 non-vented hospital full face mask was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation.The unit was visually inspected and connected to gas flow to check for leaks.Results: visual inspection revealed no damage to the returned rt046 non-vented hospital full face mask.There was also no audible leak identified from the elbow as reported by the customer.Conclusion: we were unable to determine what may have caused the leak from the elbow of the mask as reported by the customer, as no fault was found with the device.All assembled rt046 non-vented hospital full face masks are 100% leak tested, and those that fail are rejected.In addition, a sampling for pull test is conducted.The subject full face mask would have met the required specifications at the time of production.Our user instructions illustrate in pictorial format the correct set-up and proper use of the rt046 non-vented hospital full face mask.It also states the following: -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.

• 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: 18008526
• Report Number: 9611451-2023-00999
• Device Sequence Number: 7478604
• Product Code: CBK
• UDI-Device Identifier: 09420012436191
• UDI-Public: (01)09420012436191(10)2102597581(11)230503
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173060
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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: RT046M
• Device Catalogue Number: RT046M
• Device Lot Number: 2102597581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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