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

Model Number 150P

Device Problems Mechanical Problem (1384); Decrease in Pressure (1490)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 01/20/2020

Event Type  Injury  

Event Description

A complainant contacted the manufacturer alleging the continuous positive airway pressure (cpap) device he was using caused a hypertensive episode due to inadequate pressure being delivered.No immediate medical intervention was required.The event reportedly lasted two days.He was prescribed medication for hypertension at a later date, and is reportedly using an old device he still has in his possession.He stated he has not had any further issues with hypertension.The manufacturer requested return of the device for investigation.The complainant refused to return it to the manufacturer.The durable medical equipment (dme) provider listed in the equipment record as the distributor of the device was contacted and informed the manufacturer the device was provided to a patient with a different last name, and they have no record of the complainant having this device.The device was sold to the customer in 2010.The complainant stated he was "given" the device 6 or 7 years ago and had taken it to his physician's office to be checked and have the pressure set to 11 cm h2o.The complainant also stated that he took the device to a different dme recently to have the pressure checked, and that two manometers measured the pressure to be within specification of the prescribed pressure.The complainant stated he still didn't think the device was providing the correct pressure even though the manometers showed it was.A search in the manufacturer's database indicates this device has not been returned for any service since date of manufacturer in 2010.This device is no longer serviceable.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.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.As the complainant refuses to return the device for investigation, the manufacturer is unable to confirm the allegation that inadequate cpap pressure caused or contributed to the complainant's hypertensive episode.

• Brand Name: REMSTAR
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville, pa
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville, pa
• Manufacturer Contact: adam price ; 1001 murry ridge lane; murrysville, pa ; 3349303
• MDR Report Key: 9818394
• MDR Text Key: 182949949
• Report Number: 2518422-2020-00496
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 150P
• Device Catalogue Number: 150P
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2010
• 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): Other
• Patient Age: 73 YR