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

Model Number V60

Device Problems Increase in Pressure (1491); Device Sensing Problem (2917)

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

Event Date 05/04/2022

Event Type  malfunction  

Event Description

It was reported that the device had a 1009 error code (check vent: machine pressure sensor auto zero failed).There was no patient involvement when the issue occurred, no patient or user harm reported.Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.

Manufacturer Narrative

A service engineer confirmed the customer's issue and repaired the device.The service engineer replaced the data acquisition board and motor controller board to resolve the issue.The system meets the specification for the performed service and is returned to use.

Manufacturer Narrative

B5: it was reported that the device had a 1009 error code ((vent-inop): pressure regulation high.

Manufacturer Narrative

The motor controller (mc) printed circuit board assembly (pcba) was tested and no failures were identified.

• 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: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 14401800
• MDR Text Key: 291752016
• Report Number: 2031642-2022-01298
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838090996
• UDI-Public: (01)00884838090996
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2021
• 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