MAUDE Adverse Event Report: RESPRIONICS REMSTAR PLUS M SERIES

Model Number 1038863

Device Problems Nonstandard Device (1420); Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Have respironics cap machine/heated humidifier.Trying to find contact info for recall.Phone contact number on fda website is out of service.Number i was given by company, via email, does not appear to be in service.Recall number is z-1260-2009.I want to find out if my unit was included in recall.I was never notified if recall was issued.Any info you have would be helpful.Thank you.

• Brand Name: REMSTAR PLUS M SERIES
• Type of Device: REMSTAR PLUS M SERIES
• Manufacturer (Section D): RESPRIONICS
• MDR Report Key: 5260424
• MDR Text Key: 32596720
• Report Number: MW5058193
• Device Sequence Number: 1
• Product Code: BZD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1038863
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/25/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 82