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

Model Number RT045

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2023

Event Type  malfunction  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 328010067
• Report Number: 9611451-2023-01067
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 09420012436139
• UDI-Public: (01)09420012436139(10)2102546319(11)230314
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1