MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD RT046 NON-VENTED HOSPITAL FULL FACE MASK

Model Number	RT046
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint rt046 non-vented hospital full face mask is currently en-route to fisher & paykel healthcare in (b)(4) 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 to a distributor via a fisher & paykel healthcare (f&p) representative that the swivel connector elbow of a rt046 non-vented hospital full face mask was loose and fell off during mask fitting.No patient consequence was reported.
Additional Manufacturer Narrative
Ps298709 method: the complaint rt046 non-vented hospital full face mask was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation, where the unit was visually inspected.Results: visual inspection of the returned complaint mask revealed that the elbow of the mask was separated from the retainer at the welding joint.Welding marks were found all around the retainer and elbow.In addition, the mask showed a delamination of one of the headgear straps.Conclusion: we were unable to determine the cause of the reported event that the swivel connector elbow fell off during mask fitting.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.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.
Event or Problem Description
A healthcare facility in japan reported to a distributor via a fisher & paykel healthcare (f&p) representative that the swivel connector elbow of a rt046 non-vented hospital full face mask was loose and fell off during mask fitting.No patient consequence was reported.

• Brand Name: RT046 NON-VENTED HOSPITAL FULL FACE MASK
• Common Device Name: RT046 NON-VENTED HOSPITAL FULL FACE MASK
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8272954
• Report Number: 9611451-2019-00071
• Device Sequence Number: 1259579
• Product Code: CBK
• UDI-Device Identifier: 09420012436191
• UDI-Public: (01)09420012436191(10)2100205481(11)170502(17)200502
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

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 Expiration Date: 05/02/2020
• 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: 02/22/2019
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1