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 08/15/2022

Event Type  malfunction  

Event Description

The customer reported a ventilator's flow reading was off.The device was not in clinical use at the time the issue was discovered.There was no patient or user harm reported.The device was evaluated by the customer and a philips remote service engineer (rse).The customer reported that they are unable to reproduce the issue.The rse advised the customer to perform a complete performance verification test (pvt) per the service guide with passing results before placing the unit back into service.The customer is to perform a complete pvt with passing results before returning unit to service.Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.

Manufacturer Narrative

H10: multiple good faith efforts were made to retrieve device evaluation, repair, and operational status on 08/21/2022, 10/03/2022 and 10/18/2022, however, yielded no response from the customer.It is unknown if any parts or repairs have been conducted.The complaint will be processed for closure.If additional information is received at a later date, the complaint will be reopened, and a supplemental report will be submitted.

• 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: 15337014
• MDR Text Key: 304817508
• Report Number: 2031642-2022-02276
• Device Sequence Number: 1
• Product Code: MNT
• 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,User Facility
• 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: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 10/19/2022
• Date Device Manufactured: 01/10/2014
• 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