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

Model Number V60

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  malfunction  

Event Description

It was reported to philips by a customer that the unit had high tidal volume alarm.Based upon the information provided, the device was in clinical use providing therapy at the time of the event reported.No harm or injury has been indicated or alleged.The device was evaluated remotely by a philips remote service engineer (rse).Upon further inspection and review of the device, the customer stated that the unit alarmed high tidal volume on screen with audible alarm.They are not able to reset alarm.Standard test circuit and test lung was being used.There was no humidifier in place.They verified code 1210 in log, no other codes noted.Avg air, avg machine, and avg proximal readings are all within specification.All voltage readings are within specification.Advised customer to run pvt testing to see if any test fails.Rse will follow up to determine if issue is pneumatic or electronic related.

Manufacturer Narrative

Upon further investigation, additional information was received indicating the unit issue was during pvt.The customer also found he was performing the test incorrectly and the unit did not have a malfunction.Therefore, this complaint no longer meets reportability requirements.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 12601615
• MDR Text Key: 275878620
• Report Number: 2031642-2021-05242
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2021
• Date Device Manufactured: 01/28/2013
• 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