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

Model Number V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+

Device Problem Noise, Audible (3273)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported to philips that a noise was heard mixed with resonance.The device was reported to have been in patient use.There was no harm, delay in therapy, or medical intervention reported.The philips field service engineer (fse) confirmed and duplicated the reported issue.The vibration dampening ring needed to be repositioned.Following the evaluation of the device, the fse repositioned the vibration dampening ring to resolve the problem.The unit was then functionally tested and successfully passed specified tests.No other abnormality was observed.

• 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: 13122776
• MDR Text Key: 286596781
• Report Number: 2031642-2021-05917
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: 00884838033832
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/30/2021
• Date Device Manufactured: 09/16/2019
• 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