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

Model Number	RT056M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject rt056m non-vented hospital full face masks have been requested to be returned to fisher & paykel healthcare for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in india via a fisher & paykel healthcare (f&p) field representative that the elbows of two rt056m non-vented hospital full face masks disconnected from the mask during patient use.There was no patient consequence reported.
Additional Manufacturer Narrative
(b)(4).The rt056 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: the complaint rt056 non-vented hospital full face masks were discarded by the healthcare facility and therefore were unable to be returned to nz for investigation.Our investigation is therefore based on the information and photographs provided by the customer, and our knowledge of the product.Results: visual inspection of the photographs revealed that the welding marks were visible around the retainer and elbow of one of the masks.Further inspection indicated that another mask had broken retainer from the elbow.Conclusion: we are unable to determine the cause of the reported event.All assembled rt056 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 rt056 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.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in india, via a fisher & paykel healthcare (f&p) field representative that the elbows of two rt056m non-vented hospital full face masks disconnected from the mask during patient use.There was no patient consequence reported.
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 elbows of two rt056m non-vented hospital full face masks disconnected from the mask during patient use.There was no patient consequence reported.
Additional Manufacturer Narrative
(b)(4).Corrected data: section g1 - manufacturer contact office: contact person updated to mr.Diego vargas banuelos.Section d4 - udi: corrected to include (17) expiry date.The rt056 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: the complaint rt056 non-vented hospital full face masks were discarded by the healthcare facility and therefore were unable to be returned to nz for investigation.Our investigation is therefore based on the information and photographs provided by the customer, and our knowledge of the product.Results: visual inspection of the photographs revealed that the welding marks were visible around the retainer and elbow of one of the masks.Further inspection indicated that another mask had broken retainer from the elbow.Conclusion: we are unable to determine the cause of the reported event.All assembled rt056 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 rt056 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: CBK
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 17928173
• Report Number: 9611451-2023-00955
• Device Sequence Number: 6368351
• Product Code: CBK
• UDI-Device Identifier: 09420012460691
• UDI-Public: (01)09420012460691(10)2101638339(11)210518(17)240518
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K173060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2023

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: 05/18/2024
• Device Model Number: RT056M
• Device Catalogue Number: RT056M
• Device Lot Number: 2101638339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 11/01/2023; 06/12/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/20/2023; 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2021
• 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
• Patient Sex: Unknown