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

Model Number	RT047
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint rt047 vented hospital full face mask is currently en-route to fisher & paykel healthcare (f&p) in (b)(6) for evaluation.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the rt047 vented hospital full face mask came loose during patient use.There was no patient consequence.
Event or Problem Description
A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that the rt047m vented hospital full face mask came loose during patient use.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).The rt047m 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 rt047m vented hospital full face mask was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected.Results:visual inspection of the complaint device revealed that no damage was found to the headgear.Conclusion: we are unable to determine the cause of the reported event as there was no fault found with the complaint device.All assembled rt047m 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 rt047m 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: VENTED HOSPITAL FULL FACE MASK
• Common Device Name: MNT
• MDR Report Key: 11060209
• Report Number: 9611451-2020-01193
• Device Sequence Number: 3066294
• Product Code: MNT
• UDI-Device Identifier: 09420012455338
• UDI-Public: 010942001245533810
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: RT047
• Device Catalogue Number: RT047
• Device Lot Number: 2101003586
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 02/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2020
• 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