MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD HC221 CPAP HUMIDIFIER; BZD

Model Number HC221JHU

Device Problems Break (1069); Mechanical Problem (1384); Scratched Material (3020)

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

Event Type  malfunction  

Event Description

A distributor in canada reported, via a fisher & paykel healthcare (f&p) field representative, that the power cord of a hc221 cpap humidifier was damaged and had exposed copper wires.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).We have requested the return of the complaint hc221 cpap humidifier for investigation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

Ps397008 method: the complaint hc221 series cpap humidifier was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the customer reported that the hc221 series cpap humidifier had a damaged power cord and copper wires were exposed.Conclusion: without the complaint device, we are unable to confirm the reported event.The hc221 humidifier is designed to the electrical safety standards, iec601-1 and as/nzs 3200.1.The materials used in the thermoplastic components of the mains connector and the cases are flame retardant according to iec601-1 and as/nzs 3200.1.Our user instructions also state: "never operate the hc200 if it has a damaged power cord or plug".

Event Description

A distributor in canada reported, via a fisher & paykel healthcare (f&p) field representative, that the power cord of a hc221 cpap humidifier was damaged and had exposed copper wires.There was no reported patient involvement.

• Brand Name: HC221 CPAP HUMIDIFIER
• Type of Device: BZD
• 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: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14628928
• MDR Text Key: 295614182
• Report Number: 9611451-2022-00494
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K973161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HC221JHU
• Device Catalogue Number: HC221JHU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1