MAUDE Adverse Event Report: RESPIRONICS, INC. V30 CPAP; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2020

Event Type  malfunction  

Event Description

Philips respironics v30 cpap/bipap machine in use with hudson rci neptune heated humidifier with conchsmart circuits heated wire breathing circuit was in place for use the patient called the rn to the room to show what had occurred, the conchsmart circuit was coiled on the bed (mask was removed by the pt) the patient called the rn to the room to show that the circuit hose had melted.No harm to the patient.

• Brand Name: V30 CPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1740 golden mile highway; monroeville PA 15146
• MDR Report Key: 9933725
• MDR Text Key: 186823232
• Report Number: 9933725
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16790 DA