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

Model Number V60

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 10/11/2022

Event Type  malfunction  

Event Description

Philips received a complaint from the customer reporting that a v60 device indicated variation in tidal volume as per o2 percentage change.The unit was not in clinical use; there was no reported harm.The philips authorized service provider (asp) evaluated the device and determined the replacement of the gas delivery system was required to return to service.Currently the device is out of service.The customer has been provided a price quote for the recommended repair.Correction is pending customer approval.The investigation is ongoing.

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

The authorized service personnel (asp) confirmed the customer has declined repairs at this time.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 15726167
• MDR Text Key: 304797462
• Report Number: 2031642-2022-02728
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009851
• UDI-Public: 00884838009851
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Biomedical Engineer
• 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: Other
• Device Model Number: V60
• Device Catalogue Number: 1053614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 02/02/2023
• Date Device Manufactured: 04/23/2018
• 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