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 Mechanical Problem (1384); Blocked Connection (2888)

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

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported to philips an alarm for blower stopped turned on after the alarm for the patient circuit occluded alarm turned on.This event was reported to have occurred during patient use.No delay in therapy and no harm was reported.The patient was transferred to an alternative ventilator.The philips field service engineer (fse) performed a test run but the phenomenon was not duplicated.The event log revealed an occurrence of blower stalled (diagnostic code: 1134) had occurred.It was confirmed that the responded position was misaligned with the touched position, so calibration was performed but the phenomenon was not improved.The motor controller board and the touchscreen need replacing.Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.

Manufacturer Narrative

H10: the customer elected to cancel the repair.The device was returned to the customer unrepaired.Based on information provided and/or service performed, the customers alleged malfunction was not confirmed.

• 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: 15353793
• MDR Text Key: 305381552
• Report Number: 2031642-2022-02304
• 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,User Facility
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/04/2022
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 10/26/2022
• Date Device Manufactured: 01/07/2014
• 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