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

Model Number V60

Device Problem Calibration Problem (2890)

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

Event Date 01/18/2022

Event Type  malfunction  

Event Description

The customer reported that the unit alarmed data acquisition (da) pcba adc reference failed on screen during device set up.The customer reported that the unit was not in use on a patient.There was no patient harm nor delay to therapy noted.The customer contacted product support and reported that error code 100a is in the log, but not able to duplicate the complaint in biomed running on test adapter.3.3v and 2.5v references are within specification.Product support advised the customer to continue extended run-in and perform pressure accuracy test in pvt.If the problem cannot be duplicated, continue testing and return to service.Otherwise, the da pcba and da-mc cable need replacing to address the issue.

Event Description

The customer reported that the unit alarmed data acquisition (da) pcba adc reference failed on screen during device set up.The customer reported that the unit was not in use on a patient.There was no patient harm nor delay to therapy noted.The customer contacted product support and reported that error code 100a is in the log, but not able to duplicate the complaint in biomed running on test adapter.3.3v and 2.5v references are within specification.Product support advised the customer to continue extended run-in and perform pressure accuracy test in pvt.If the problem cannot be duplicated, continue testing and return to service.Otherwise, the da pcba and da-mc cable need replacing to address the issue.

Manufacturer Narrative

The customer reported that they are unable to duplicate the complaint in the biomed shop while running on test adapter.The voltage references are within specifications.The da-mc cable was manually manipulated to duplicate the error but was not able to reproduce the failure.Product support followed up with the customer and stated that all testing with the unit passed and the unit had been returned to service.No part was replaced.

• 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: 13452115
• MDR Text Key: 285155784
• Report Number: 2031642-2022-00369
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/04/2022
• Supplement Dates Manufacturer Received: 02/02/2022
• Supplement Dates FDA Received: 03/01/2022
• Date Device Manufactured: 12/27/2013
• 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