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

Model Number V60

Device Problem Increase in Pressure (1491)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

It was reported that the device's inlet pressure increased to over 150 psi.There was no patient involvement when the event occurred, no patient or user harm reported.Per the diagnostics performed by the engineer, the customer stated receiving an error for an o2 inlet pressure being too high.It was reported that the device was at 73 psi, then slowly increased to 150 psi.The remote service engineer indicated that the issue could be from trapped o2 pressure between the manifold and the o2 inlet.The customer disconnected the o2 source and verified the o2 inlet pressure.It was reported that when the o2 was disconnected, the o2 inlet went down to 0.2 psi.After reconnecting the o2 source, the o2 inlet pressure started at 50 psi, and after 30 seconds, it went up to 90 psi.It was verified that the o2 solenoid valve was operating properly.The customer reported that they would test a different v60 ventilator with the same set up, to try and verify that the h tank was operating fine.The customer verified the regulator on top of the h tank was defective and caused the high 2 inlet pressure readings.The customer used a different o2 source, and the device operated as intended.

• 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: 14186701
• MDR Text Key: 289869671
• Report Number: 2031642-2022-01077
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• 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
• Date Manufacturer Received: 04/07/2022
• Date Device Manufactured: 12/31/2010
• 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