MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; HEATED RESPIRATORY HUMIDIFIER

Model Number	HC150JHU
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor in california reported via a fisher & paykel healthcare (f&p) field representative that the power cord of an hc150jhu heated respiratory humidifier was torn.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4).Method: the subject, hc150jhu respiratory humidifier was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information and photography provided by the distributor and our knowledge of the product.Results: visual inspection of the provided photography confirmed that the outer insulation had been compromised, resulting in the exposure of the internal wiring and copper conducters.Conclusion: based on the visual evaluation of the provided photography, and our knowledge of the product, the reported event was likely due to one or more of the following factors: - wear and tear due to repeated bending, flexing, or pulling of the cord.- abrasion caused by contact with sharp edges or rough surfaces.- improper handling or storage practices, such as tightly wrapping or compressing the cord.- pinching or crushing of the cable under furniture, doors, or heavy objects.- exposure to elevated temperatures or heat sources that can degrade insulation.The hc150 respiratory humidifier is used to warm and humidify gases delivered to patients requiring continuous positive airway pressure (cpap) therapy or mask ventilation.The user instructions states the following: - never operate the hc150 if it has a damaged cord or plug, if it is not working properly, or if any part of either the hc150 or the humidification chamber is dropped or damaged, or dropped into water.- keep the cord away from heated surfaces.
Event or Problem Description
A distributor in california reported via a fisher & paykel healthcare (f&p) field representative that the power cord of an hc150jhu heated respiratory humidifier was torn.There was no reported patient consequence.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: HEATED 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 ; 9494341005
• MDR Report Key: 24646065
• Report Number: 9611451-2026-01046
• Device Sequence Number: 15913243
• Product Code: BTT
• UDI-Device Identifier: 09420012400413
• UDI-Public: (01)09420012400413(10)2100718903(11)190307
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K003973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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
• Device Model Number: HC150JHU
• Device Catalogue Number: HC150JHU
• Device Lot Number: 2100718903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown