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

Model Number RT041

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device is currently en route to fisher & paykel healthcare in (b)(4) for evaluation, to determine if it had a malfunction which might have lead to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher and paykel healthcare representative that the mask seal of an rt041 full face mask separated from the mask frame.No patient consequence was reported.

Manufacturer Narrative

The complaint rt041 full face mask is not available for investigation as it was not received by fisher & paykel healthcare (b)(4).Our analysis is accordingly based on information provided by the hospital and our knowledge of the product.The mask was reported to be in use for approximately 2-3 hours.The nurse also reported that during therapy, the patient was not restless and did not try to remove the mask.Without the complaint device, we are unable to determine that may have caused the problem reported by the hospital.If the complaint device was returned, it would have been visually inspected.The rt041 full face mask features a mask base, seal, and headgear.The mask seal is inserted into the mask base and is secured with glue.Each assembled mask seal is inspected to ensure it is correctly inserted and there are no unacceptable gaps between the seal and the base.Samples are taken and the mask seals are pulled apart after 24 hours to ensure they meet or exceed the required detachment force before the assembled product can be released.

Event Description

A hospital in (b)(6) reported via a fisher and paykel healthcare representative that the mask seal of an rt041 full face mask separated from the mask frame.No patient consequence was reported.

• Brand Name: NON VENTED HOSPITAL FULL FACE MASK
• Type of Device: BYG
• 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: raymond yan ; 173 technology dr. suite 100; irvine, CA 92618-2216 ; 8007923912
• MDR Report Key: 5580484
• MDR Text Key: 42761116
• Report Number: 9611451-2016-00129
• Device Sequence Number: 1
• Product Code: BYG
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K083122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT041
• Device Catalogue Number: RT041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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