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

Model Number V60

Device Problems Device Displays Incorrect Message (2591); Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Phone number removed from grid: (b)(6).A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that the high blower temperature alarm occurred.There was no patient involvement.

Manufacturer Narrative

The manufacturer¿s international service technician confirmed the reported blower temperature issue.The manufacturer¿s international service technician replaced the blower to address the reported problem.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed.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.The lm20 temperature sensor output was verified within specifications.The blower assembly was installed into an fi test ventilator and booted up in normal ventilation mode.No errors were detected.The fi test ventilator was allowed to run four (4) hours on normal ventilation mode.No error codes were generated.The fi test ventilator was booted into diagnostic mode and allowed to run another four (4) hours.No error codes were generated and the blower temperature remained at the lower end of normal operating temperatures.The test ventilator booted up and delivered breaths on ac.The air flow accuracy test was performed and passed.The determination could not be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is no relationship of the device to the reported problem.The blower assembly passed all testing.A high blower temperature alarm (1122 error code) could not be duplicated.There were no faults found with the blower assembly.

• 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: 6834113
• MDR Text Key: 84320711
• Report Number: 2031642-2017-02790
• 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: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• 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: 11/29/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2013
• 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