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

Model Number RT040

Device Problem Device Handling Problem (3265)

Patient Problem Pressure Sores (2326)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are in the process of obtaining further information from the hospital to determine if fph's product caused or contributed to the reported event.Our investigation is in progress and we will provide a follow up report upon completion of our investigation.

Event Description

A hospital in the (b)(6) reported that patients were experiencing pressure sores from the rt040m hospital full face masks.

Manufacturer Narrative

(b)(4).Method: the complaint rt040m vented hospital full face masks had been destroyed at the hospital facility.An attempt was made to obtain additional information regarding the reported fault but no response was received from the hospital staff.Our analysis is accordingly based on the event description and our knowledge of the product.Results: the hospital staff reported that the patients were experiencing pressure sores while using the subject full face mask.A lot check was not performed as lot information was not provided.Conclusion: we are unable to determine the root cause of the problem reported by the hospital staff.Since the reported incident, the fph representative has visited the hospital and discussed the correct fitting of the fph hospital masks.Furthermore, the fph representative has offered an in-service training to the hospital staff regarding the correct fitting and sizing of fph hospital masks.The user instructions illustrate in pictorial format the correct set-up and proper us of the rt040 vented hospital full face mask.It also state the following: "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 lost of therapy, serious injury or death."; "if the patient experience skin irritations, consult physician.".

Event Description

A hospital in the (b)(6) reported to a fisher and paykel healthcare (fph) field representative that patients were experiencing pressure sores from the rt040m vented hospital full face masks.It was further reported that the complaint masks were destroyed at the hospital facility.

• Brand Name: VENTED HOSPITAL 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9194534000
• MDR Report Key: 5556159
• MDR Text Key: 42161741
• Report Number: 9611451-2016-00126
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT040
• Device Catalogue Number: RT040
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2016
• 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