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

Model Number V60 PLUS

Device Problem Leak/Splash (1354)

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

Event Date 07/05/2022

Event Type  malfunction  

Manufacturer Narrative

Reporting address state: (b)(6).Reporting address postal: (b)(6).Reporter phone #: (b)(6).

Event Description

The customer called technical support (ts) reporting that the device does not register the parameter "patient leak".The customer reported there was no patient involvement at the time the issue was discovered.The manufacturer's product support engineer (pse) evaluated the device and could not duplicate the reported problem.The pse was unable to duplicate the reported problem.A full performance verification has been performed and the device passed all test successfully.The repair was canceled and the unit was returned per the customer's request.No parts were replaced.No parts are expected to be returned for failure investigation; therefore, the root cause at the component level could not be determined.

• 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: 14992356
• MDR Text Key: 304512383
• Report Number: 2031642-2022-01866
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838089280
• UDI-Public: 0884838089280
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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

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 PLUS
• Device Catalogue Number: 1137276
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/12/2022
• Date Device Manufactured: 06/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1