MAUDE Adverse Event Report: NON-VENTED HOSPITAL FULL FACE MASK; MNT

Model Number	RT046
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently in the process of investigation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A distributor in (b)(6) reported that the elbow of a rt046 non-vented hospital full face mask disconnected from the swivel connector.There was no reported patient involvement.
Event or Problem Description
A distributor in japan reported that the elbow of three rt046 non-vented hospital full face masks disconnected from the swivel connector.There was no reported patient involvement.
Additional Manufacturer Narrative
(b)(4).Section b5 was corrected.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: two complaint rt046 non-vented hospital full face masks were returned to fisher & paykel healthcare (f&p) in new zealand for evaluation.The units were visually inspected.Results: visual inspection of the returned complaint masks revealed that the elbows of the mask were separated from the retainers.Conclusion: however, we are unable to determine the cause of the reported event.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: MNT
• MDR Report Key: 11625451
• Report Number: 9611451-2021-00371
• Device Sequence Number: 2899758
• Product Code: MNT
• UDI-Device Identifier: 09420012436191
• UDI-Public: 010942001243619110
• 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: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: RT046
• Device Catalogue Number: RT046
• Device Lot Number: 2100205481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2017
• 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