MAUDE Adverse Event Report: RESPIRONICS, INC REMSTAR AUTO A-FLEX; VENTILATOR,NON-CONTINUOUS RESPIRATOR

Model Number DS550HS

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 07/04/2014

Event Type  Injury  

Event Description

The manufacturer received information on (b)(6) 2015 from a durable medical equipment (dme) supplier that a device user alleged that a continuous positive airway pressure (cpap) device stopped working on (b)(6) 2014.As per the report from the dme, the end user alleged that she was hospitalized as a result of a decline in "cardiopulmonary disease" because the device was not replaced by the dme "in a timely manner".The date of admission and length of stay are unknown at this time.The manufacturer's investigation is on-going.Upon completion of the manufacturer's investigation, a follow up report will be filed.

Manufacturer Narrative

The manufacturer has completed the evaluation of a cpap device associated with an allegation that a cpap device stopped working and the user required to be hospitalized.Initially, the manufacturer's report indicated that the date of the event was (b)(6) 2014.The manufacturer received updated information that the date of the alleged event was (b)(4) 2014.The device was returned to the manufacturer for evaluation.During the manufacturer's evaluation, the review of device's log confirmed that the device stopped working on the date of (b)(6) 2014.The flow sensor of the device's board had evidence of dirt/dust contamination and water ingress/corrosion to the sensor.Due to this fault condition, the cpap device stopped working and issued an audible alert and a visual alert, the lcd display indicated "service required".Patient labeling warns the user that if they detect any unexplained changes in the performance of the unit, if the unit is dropped or mishandled, if liquid or water is spilled into the enclosure or if the enclosure is broken, to stop using the device, unplug it and seek assistance from respironics or an authorized service center.Patient labeling also warns, "cleaning or replacing the filters: under normal usage, you should clean the gray foam filter at least once every two weeks and replace it with a new one every six months.The white ultra-fine filter is disposable and should be replaced after 30 nights of use or sooner if it appears dirty.Do not clean the ultra-fine filter".The intended use of this device is only for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing more than 66 pounds.The short-term loss of therapy for this patient class does not pose a significant health or safety risk.The manufacturer concludes the reported event was the result of contamination during use.Based on the available information, the manufacturer concludes no further action is necessary.

• Brand Name: REMSTAR AUTO A-FLEX
• Type of Device: VENTILATOR,NON-CONTINUOUS RESPIRATOR
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge lane; murrysville 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge lane; murrysville 15668
• Manufacturer Contact: wilfredo alvarez ; 312 alvin drive; new kensington 15068 ; 7243349303
• MDR Report Key: 5270074
• MDR Text Key: 32750336
• Report Number: 2518422-2015-04081
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS550HS
• Device Catalogue Number: DS550HS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization