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

Model Number RT046

Device Problems Disconnection (1171); Connection Problem (2900)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of investigation.We will provide a follow up report upon completion of investigation.

Event 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 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.

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
• Type of Device: MNT
• MDR Report Key: 11625451
• MDR Text Key: 251940215
• Report Number: 9611451-2021-00371
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 09420012436191
• UDI-Public: 010942001243619110
• Combination Product (y/n): N
• PMA/PMN Number: K170367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2017
• 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