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

Model Number V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+

Device Problems Defective Alarm (1014); Calibration Problem (2890)

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

Event Date 12/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

A customer was performing a post-use check in the hospital's clinical engineer room and found that a check vent alarm had occurred and contacted philips.The device was in clinical use at the time of the event however, there was no report of patient or user harm and neither delay in therapy nor medical intervention reported.The reported issue was not duplicated by a test run performed.Occurrence records of "check vent: primary alarm failed (diagnostic code:1102) (power speaker fail, motor speaker fail)" and "check vent: cpu pcba adc failed (diagnostic code:111e) were confirmed in the event log.The central processing unit (cpu) board and speaker#1 and speaker#2 were replaced to prevent recurrence.Unit was cleaned, run-in and functionally tested.

Manufacturer Narrative

A central processing unit (cpu) and 2 speakers were returned for failure analysis.An investigation was performed, and the returned cpu ran for extended period in power-cycled environment and no errors occurred.An investigation was performed on the returned speakers and the returned speakers operated normally on bench and in ventilator.There were no faults found on the returned parts.

• 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: 13170369
• MDR Text Key: 283270295
• Report Number: 2031642-2022-00057
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: 00884838033832
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2017
• 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