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

Model Number V60

Device Problem Temperature Problem (3022)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer reported a high blower temperature (e/c-1122) occurred.The unit was being used on a patient at the time the reported issue occurred; however, there was no patient harm.

Manufacturer Narrative

During further investigation (fi), a visual inspection of the blower assembly outer surface 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 lm20 temperature sensor output was verified.The blower assembly was installed into an fi test ventilator.The ventilator was booted up in normal ventilation mode and the ventilator remained operational with no errors detected.The test ventilator booted up and delivered breaths on ac.The device was allowed to run a minimum of 4 hours on normal ventilation mode and no error codes were generated.The fi test ventilator with the returned blower assembly installed was allowed to run another minimum of 4 hours on diagnostic mode with the restrictor removed from the gas outlet port.The test ventilator booted up and delivered breaths on ac and did not generate any errors while operating in diagnostic mode.Blower temperature readings remained below the nominal = 55¿.The air flow 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 6670023
• MDR Text Key: 78668345
• Report Number: 2031642-2017-02075
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• 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: 06/27/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1