MAUDE Adverse Event Report: Fisher & Paykel Healthcare Ltd Fisher & Paykel Healthcare; Respiratory Humidifier

Model Number	PT101US
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: Fisher & Paykel Healthcare
• Common Device Name: Respiratory Humidifier
• 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: diego vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; +1(949)434-1005
• MDR Report Key: 50909717
• Report Number: 9611451-2026-02819
• Device Sequence Number: 6076674
• Product Code: BTT
• UDI-Device Identifier: 09420012422347
• UDI-Public: (01)09420012422347(10)2100671481(11)190110
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/27/2026

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
• Operator of Device: Health Professional
• Device Model Number: PT101US
• Device Catalogue Number: PT101US
• Device Lot Number: 2100671481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 9611451-09/10/2025-001-C
• Patient Sequence Number: 1
• Patient Sex: Unknown