MAUDE Adverse Event Report: PHILIPS RESPIRONICS; NEBULIZER HEATER

Model Number 1157264

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2015

Event Type  malfunction  

Event Description

Crt was changing the water bottle connected to the nebulizer heater.Heater sparked at electrical connection on the heater.Heater immediately removed from service and sent to biomed for disposal.No repair on these heaters.Crt and patient not harmed.

• Type of Device: NEBULIZER HEATER
• Manufacturer (Section D): PHILIPS RESPIRONICS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 4568592
• MDR Text Key: 5551336
• Report Number: 4568592
• Device Sequence Number: 1
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1157264
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 YR