MAUDE Adverse Event Report: RESPIRONICS, INC M PROFILE LITE MASK; VENTILATOR,NON-CONTINUOUS RESPIRATOR

Model Number 1004116

Device Problems Partial Blockage (1065); Physical Property Issue (3008)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2015

Event Type  malfunction  

Event Description

A caregiver alleged that the exhalation port of the profile lite nasal mask was slightly blocked, resulting in high paco2 levels in the patient.The patient was reported to have been hospitalized for pneumonia when the issue was noted.There is no report of serious or permanent injury.The manufacturer's investigation is on-going.Upon completion of the manufacturer's investigation, a follow up report will be filed.

Manufacturer Narrative

The manufacturer evaluated the mask and tested for co2 rebreathing and total mask leak.The mask passed testing within mask requirements.No other visual defects were detected.The manufacturer concludes no further action is necessary.

• Brand Name: M PROFILE LITE MASK
• Type of Device: VENTILATOR,NON-CONTINUOUS RESPIRATOR
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge lane; murrysville 15668
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge lane; murrysville 15668
• Manufacturer Contact: wilfredo alvarez ; 312 alvin drive; new kensington 15068 ; 7243349303
• MDR Report Key: 5149506
• MDR Text Key: 28601933
• Report Number: 2518422-2015-03381
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K954207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1004116
• Device Catalogue Number: 1004116
• Device Lot Number: 140829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization