MAUDE Adverse Event Report: PHILIPS RESPIRONICS INC. DREAMSTATION BIPAP AVAPS30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DSX1130H11C

Device Problems Contamination (1120); Decrease in Pressure (1490)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/11/2020

Event Type  Injury  

Event Description

The manufacturer received information alleging a dreamstation bipap avaps30 was delivering low pressures.The patient was admitted to the hospital and placed on a ventilator for one day.The device was returned to the manufacturer's quality product investigation laboratory for further investigation.The device's downloaded event log was reviewed.The event log indicates on the day of the reported event, the pressures were low.The manufacturer was unable to duplicate the customer's complaint.The manufacturer tested the device at the prescribed pressures and found the device to deliver set pressures.The device was visually inspected and found evidence of water ingress and dust and dirt contamination to the device.Product labeling states,"if you notice any unexplained changes in the performance of the device, if it is making unusual sounds, if water is spilled inot the enclosure, or if the enclosure is cracked or broken, discontinue use and contact your home care service provider." product labeling also states,"remove the tank, empty all water, and replace the empty tank before transporting the humidifier base." although the device's event log indicates the device delivered low pressures, the manufacturer was unable to duplicate this event.The device is not intended for life support.

• Brand Name: DREAMSTATION BIPAP AVAPS30
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS RESPIRONICS INC.; 1001 murry ridge lane; murrysville, pa
• Manufacturer (Section G): PHILIPS RESPIRONICS INC.; 1001 murry ridge lane; murrysville, pa
• Manufacturer Contact: adam price ; 1001 murry ridge lane; murrysville, pa
• MDR Report Key: 10493677
• MDR Text Key: 205664307
• Report Number: 2518422-2020-02016
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX1130H11C
• Device Catalogue Number: DSX1130H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2018
• 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
• Patient Age: 72 YR