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

Model Number V60

Device Problem Pressure Problem (3012)

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

Event Date 12/21/2021

Event Type  malfunction  

Event Description

The customer reported a technical malfunction of the ventilator.There was no patient involvement at the time the issue was discovered.No patient or user harm was reported.There were 2 problems: the electrical test does not pass, and the high-pressure leak test does not pass.It turns out that the issue with the electrical test has been solved.However, the issue of the high-pressure leak still remains.The customer performed the preventive maintenance.One issue was isolated because it did not pass the electrical test.Several philips service actions were performed.The high-pressure test did not pass.Further information has been requested.

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

Field service engineer confirmed replacement of the complete gas delivery system (gds) module.Complete test with the customer, the test was conclusive.The equipment is fully operational.

Manufacturer Narrative

Based on the information received, it has been identified that mfr report#: 2031642-2021-05274 is the correct report and is the primary complaint.Mfr report#: 2031642-2021-05912 has been identified to be a duplicate and should be nulled.

• 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: 13114333
• MDR Text Key: 286357125
• Report Number: 2031642-2021-05912
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 12/21/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 03/31/2022; 06/03/2022
• Supplement Dates FDA Received: 04/08/2022; 06/03/2022
• 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