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

Model Number V60 VENTILATOR,JAPAN OPT: CFLEX,AVAPS

Device Problem Volume Accuracy Problem (1675)

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

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

Reporting address state:(b)(6).Reporting address postal:(b)(6).Reporting institution phone :(b)(6).

Event Description

It was reported to philips when spontaneous respiration was intentionally set up using a test lung, the device did not detect spontaneous respiration, i.E., volume waveform was not displayed.There was no patient involvement or harm.This event was reported to have occurred during pre-use checking in the medical engineer room, which is outside of clinical use.There was no delay to therapy.Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.

Manufacturer Narrative

The repair for this unit cannot be conducted at this time due to the part(s) speculated for the repair being on backorder.An order for the part will be placed to conduct the repair of this unit.When the parts become available the repairs will be conducted.If new information is received and suggests that the device has additional malfunctions, the record will be reopened, and an investigation will be performed.

Manufacturer Narrative

The fse replaced the flow sensor assembly.The reported problem was reported to have been fixed.The device passed the required performance verification tests per philips standard and was returned to service.No other abnormality was observed.

• 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: 15350068
• MDR Text Key: 305369961
• Report Number: 2031642-2022-02293
• Device Sequence Number: 1
• Product Code: MNT
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 VENTILATOR,JAPAN OPT: CFLEX,AVAPS
• Device Catalogue Number: 1053618
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2022
• Date Device Manufactured: 03/16/2012
• 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