MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION CPAP PRO W/HUM/HT/CELL, CAN; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number CAX400T12C

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Respiratory Acidosis (2482)

Event Date 02/20/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging a patient developed hypercapneic respiratory failure when their continuous positive airway pressure (cpap) device failed to operate as designed.The patient was admitted to the hospital in response to the event.The device has yet to be returned to the manufacturer for evaluation.At this time, we are unable to confirm the allegation.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer received the devices for evaluation.The investigation by the manufacturer found no evidence of the dreamstation cpap/humidifier delivering pressures outside of the set parameters.The devices passed all testing and were found to operate as designed.The manufacturer is unable to confirm the allegation of "device failed to operate as designed".The patient was discharged home.

• Brand Name: DREAMSTATION CPAP PRO W/HUM/HT/CELL, CAN
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11476558
• MDR Text Key: 239553060
• Report Number: 2518422-2021-00736
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959034518
• UDI-Public: 00606959034518
• Combination Product (y/n): N
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CAX400T12C
• Device Catalogue Number: CAX400T12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HUMIDIFIER- S/N (B)(6)OXYGEN-NO INFO; HUMIDIFIER- S/N (B)(4)OXYGEN-NO INFO
• Patient Outcome(s): Hospitalization
• Patient Age: 95 YR