MAUDE Adverse Event Report: RESPIRONICS, INC. DISPOSABLE ADULT PASSIVE CIRCUIT NO WATER TRAP; NONE

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/29/2014

Event Type  Injury  

Event Description

Patient ended up going to hospital per patients husband because the ventilators were not working right.It was determined that the ventilator's were working fine and that it was the circuit that was the issue with the ventilation to the patient.It was thought that the family may be taking the whisper swivel out of the circuit and using the circuit incorrectly.

• Brand Name: DISPOSABLE ADULT PASSIVE CIRCUIT NO WATER TRAP
• Type of Device: NONE
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 4569784
• MDR Text Key: 5477886
• Report Number: MW5041078
• Device Sequence Number: 1
• Product Code: BZE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: 1073228
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 54