MAUDE Adverse Event Report: RESPIRONICS, INC. HEATED HUMIDIFIER; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1056215
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Cancer (3262)
Type of Reportable Event	Serious Injury
Event or Problem Description
An end user alleges that he developed carcinoma of the throat due to breathing what he described as a foul odor from his heated humidifier when it ran out of water during an unknown amount of nights.The heated humidifier was in use with a continuous positive airway pressure (cpap) device.The model and serial number of the cpap are unknown at this time.The user stated he was unaware that his humidifier settings had changed "somehow" in december, 2015, but was aware that there was no water left in his humidifier chamber at the end of his therapy sessions each night.The user was diagnosed with carcinoma later (exact date of diagnosis is unknown), and attributes the diagnosis to the odor coming from his humidifier.The user stated he cleaned the humidifier and chamber, corrected the humidity setting, and has continued to use both the humidifier and cpap.The user stated that although there was no malfunction of the devices in use at the time, he feels the manufacturer should have some sort of warning for the users if they run out of water in the humidifier during the night.The manufacturer has requested return of all devices in use at the time of the alleged event.The investigation is on-going.Upon completion of the manufacturer's investigation, a follow up report will be filed.
Additional Manufacturer Narrative
The manufacturer made numerous requests for return of the heated humidifier for investigation.The end user declined to return the device, and continued to use it until recently when he received a different cpap.The heated humidifier is an accessory for the respironics remstar and bipap therapy devices to provide moisture to the patient circuit.It is intended for use in spontaneously breathing patients weighing over 30 kg (66 lbs), in the home or hospital/institutional environment, who use mask-applied positive pressure ventilation therapy.The user is warned in the heated humidifier user manual to "use the humidifier only for its intended use as described in manual.Use only accessories recommended by respironics.Periodically inspect the humidifier for signs of wear or damage.Never operate the humidifier if any parts are damaged, if it is not working properly, or if the humidifier has been dropped or mishandled.Do not use the humidifier if the water tank is leaking or damaged in any way.Have any damaged parts replaced before continuing use.If you notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, if it has been dropped or mishandled, if water is spilled into the enclosure, or if the enclosure is broken, disconnect the power cord from the therapy device and discontinue use.Contact your home care provider." the user is further cautioned that "the humidifier number setting must remain on "0" if there is no water in the water tank." the device history record was reviewed and indicated the heated humidifier passed all testing during the manufacturing process.The user's heated humidifier has not returned for service since date of manufacture.A search of the manufacturer's complaint records yielded no similar allegations of developing throat carcinoma as a result of water being depleted from the heated humidifier during therapy sessions without a warning to the user.Based on the information available, the manufacturer is unable to confirm the reported event, and concludes that no further action is necessary.

• Brand Name: HEATED HUMIDIFIER
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 7338334
• Report Number: 2518422-2018-00611
• Device Sequence Number: 13684815
• Product Code: BZD
• UDI-Device Identifier: 00606959046375
• UDI-Public: 00606959046375
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1056215
• Device Catalogue Number: 1056215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other