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

Model Number RT046

Device Problems Break (1069); Peeled/Delaminated (1454)

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

Event Date 12/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information from the hospital to determine if the complaint rt046 mask had a malfunction which might have led to the reported event.We will provide a follow up report once we have completed our evaluation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (fph) field representative that the headgear strap of an rt046 non vented hospital full face mask broke during use.No patient consequence was reported.

Manufacturer Narrative

Ps298510 method: the complaint device was not available for investigation, however, the customer could provide photos of the complaint device.Results: visual inspection of the provided photographs revealed that the headgear layers were coming apart from two areas of the rt046 mask headgear.Conclusion: we were unable to determine the root cause of the reported damage found to the rt046 mask.The rt046 hospital non-vented full face mask features a mask base, seal, and headgear.The mask is intended to enable non-invasive 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.Our user instructions illustrate in pictorial format the correct set-up and proper use of the rt046 hospital non-vented full face mask.It also states the following: - inspect the mask for damage.Discard the mask if any parts are broken or if the seal is torn.- verify that the therapy device (i.E.Ventilator or flow source) including all alarms and safety systems are functioning correctly and that it is supplying the correct pressure(s).- 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 Description

A hospital in the uk reported via a fisher & paykel healthcare (fph) field representative that the headgear strap of an rt046 non vented hospital full face mask broke during use.No patient consequence was reported.

• Brand Name: HOSPITAL NON-VENTED FULL FACE MASK
• Type of Device: CBK
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8300691
• MDR Text Key: 134882329
• Report Number: 9611451-2019-00083
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K173060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/05/2019

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
• Device Operator: Health Professional
• Device Model Number: RT046
• Device Catalogue Number: RT046
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 01/05/2019
• Supplement Dates FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1