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

Model Number V60

Device Problem Leak/Splash (1354)

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

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The international philips field service engineer (fse) reported that a ventilator was experiencing a leak problem.Patient or user involvement information is unknown and was requested from the philips international field service engineer (fse).No patient or user harm has been reported.The device was evaluated by the customer and an international philips field service engineer (fse).In view of the logs there was no message about a probable leak internal to the v60.The high tidal volume alarms correspond to a message of patient status and therefore of use and not leakage.The fse sent the customer technician an intervention quote for complete verification of the ventilator¿s performance before being put back into service.Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.

Manufacturer Narrative

The philips field service engineer (fse) evaluated the device and conducted a leak and performance test.No problems were spotted, and no pressure was loss.The system meets the specification for the performed service and is returned to use.Moreover, further information regarding the repair was requested.No response was received at this time.No other anomalies were reported.If pertinent information is later received, 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: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 13904792
• MDR Text Key: 287924559
• Report Number: 2031642-2022-00761
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009851
• UDI-Public: 00884838009851
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Device Catalogue Number: 1053614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 04/12/2022
• Supplement Dates FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• 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