MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FULL FACE MASK; MNT

Model Number RT040

Device Problem Human-Device Interface Problem (2949)

Patient Problem Pressure Sores (2326)

Event Date 11/02/2018

Event Type  Injury  

Manufacturer Narrative

Method: the complaint rt040 vented full face mask had been destroyed at the hospital facility and was not returned to fisher & paykel healthcare for further investigation.Our analysis is accordingly based on the event description, additional information provided by the hospital and our knowledge of the product.Conclusion: the hospital staff reported that the patient developed the pressure sore as a result of the patient being very thin and the duration/nature of the therapy rather than the mask itself.They aren't raising any complaints related to the functionality or the performance of the rt040 mask.Patient had been on niv for a number of days with high ipap/epap pressures and only very short breaks for drinks/food due to his condition.It was advised to us that the patient understood it was not possible for that pressure damage to be avoided due to the nature of the therapy.He had an appropriate dressing on his nose during the whole period of niv treatment.We were also made aware that patient died, however the f&p rt040 mask did not cause or contribute to the death of the patient.Since the reported incident, the f&p representative reached out to the hospital to provide further training for the correct fitting of the f&p hospital masks.However, the training was refused by the customer.The user instructions that accompany the rt040 vented full face mask state: 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.If the patient experiences skin irritations, consult physician.

Event Description

A hospital in the (b)(6) reported that a patient obtained a grade 4 pressure sore around the bridge of the nose during his use of non-invasive ventilation (niv) therapy while using a fisher & paykel healthcare (f&p) rt040 vented full face mask.It was further reported by the hospital that the patient was extremely thin and was using the rt040 mask for niv for quite a long time (weeks) at quite high pressures (approx.20-25cm).The staff also reported that the pressure sore was caused as a result of patient being very thin and the duration/nature of the therapy rather than the mask itself.We were also made aware that patient died after the incident occurred, however the rt040 mask did not cause or contribute to the death of the patient.

• Brand Name: FULL FACE MASK
• Type of Device: MNT
• 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 8454690
• MDR Text Key: 139961217
• Report Number: 9611451-2019-00267
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K060044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RT040
• Device Catalogue Number: RT040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• 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
• Patient Outcome(s): Hospitalization