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

Model Number RT041

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of finalising our investigation.We will provide a follow up report upon completion of investigation.

Event Description

A distributor reported on behalf of a healthcare facility in (b)(6) via a fisher & paykel healthcare (f&p) field representative that the velcro tore from the headgear strap of a rt041l non-vented hospital full face mask during use.There was no patient consequence.

Manufacturer Narrative

(b)(4).The rt041 non-vented hospital full face mask features a mask base, seal, and headgear.The mask is an oronasal patient interface for use as an accessory to therapy devices providing non-invasive bi-level or continuous positive airway pressure support therapy.This mask is for spontaneously breathing adult patients with respiratory insufficiency or respiratory failure who are suitable for non-invasive positive pressure support therapy in a hospital or clinical setting.Method: the complaint rt041 non-vented hospital full face mask was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information and photograph provided by the customer, and our knowledge of the product.Results: visual inspection of the provided photograph revealed that the headgear velcro was separated from the headgear.Conclusion: we were unable to determine the cause of the reported damage found to the rt041 headgear.The supplier of the headgear has been notified of this issue and is conducting their own investigation.Our user instructions illustrate in pictorial format the correct set-up and proper use of the rt041 non-vented hospital full face mask.It also states the following: verify that the therapy device, including alarms and safety systems, have been validated prior to use.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 results in loss of therapy, serious injury or death.

Event Description

A distributor reported on behalf of a healthcare facility in south africa via a fisher & paykel healthcare (f&p) field representative that the velcro tore from the headgear strap of a rt041 non-vented hospital full face mask during use.There was no patient consequence.

• Brand Name: NON-VENTED HOSPITAL 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: 11276768
• MDR Text Key: 231309450
• Report Number: 9611451-2021-00113
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 09420012429858
• UDI-Public: 010942001242985810
• Combination Product (y/n): N
• PMA/PMN Number: K083122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

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: RT041
• Device Catalogue Number: RT041
• Device Lot Number: 2101295290
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1