MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that the alarm vent inop , e/c 1002 blower temperature too high was activated.The unit was being used on a patient at the time the reported issue occurred however, there was no patient harm.

Manufacturer Narrative

Date of report: 21sep2018.Date of manufacturer: 07jun2018.(b)(4).During further investigation (fi), a visual inspection of the blower assembly revealed no evidence of damage or contamination.The blower assembly end cap was removed and a visual inspection of the impellers and surroundings did not reveal any signs of rubbing, damage, or contamination.Before applying power to the blower assembly, the temperature sensor output was verified and found to be within specifications.The blower assembly was installed in an fi test ventilator.The test ventilator booted up and delivered breaths.The test ventilator did not generate any errors.No failures occurred during testing.The airflow accuracy test was performed and passed.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 7343760
• MDR Text Key: 102607709
• Report Number: 2031642-2018-00584
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT MASK AND CIRCUIT:UNKNOWN
• Patient Age: 80 YR
• Patient Weight: 68