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

Model Number	RT040
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in (b)(6), via a fisher & paykel healthcare (f&p) field representative that the headgear strap of a rt040m vented hospital full face mask was broken.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The rt040 vented hospital full face mask features a mask base, seal, and headgear.The mask is an oronasal patient interface for use as an accessory to therapy devices providing non-invasive bi-level or continuous positive airway pressure support therapy.This mask is for spontaneously breathing adult patients with respiratory insufficiency or respiratory failure who are suitable for non-invasive positive pressure support therapy in a hospital or clinical setting.Method: the complaint (b)(4) vented hospital full face mask was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photograph provided by the customer, and our knowledge of the product.Results: visual inspection of the provided photograph revealed that the headgear velcro was separated from the headgear.Conclusion: we were unable to determine the cause of the reported damage found to the rt040 headgear.The supplier of the headgear has been notified of this issue and is conducting their own investigation.Our user instructions illustrate in pictorial format the correct set-up and proper use of the rt040 vented hospital full face mask.It also states the following: verify that the therapy device, including alarms and safety systems, have been validated prior to use.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 results in loss of therapy, serious injury or death.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in china, via a fisher & paykel healthcare (f&p) field representative that the headgear strap of a rt040m vented hospital full face mask was broken.There was no patient involvement.

• Brand Name: VENTED HOSPITAL FULL FACE MASK
• Common Device Name: MNT
• MDR Report Key: 11210765
• Report Number: 9611451-2021-00072
• Device Sequence Number: 4104020
• Product Code: MNT
• UDI-Device Identifier: 09420012429834
• UDI-Public: (01)09420012429834(10)2101008440(11)200213
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2020

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: RT040
• Device Catalogue Number: RT040
• Device Lot Number: 2101008440
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/24/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 03/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2020
• 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