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

Model Number V60

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

Spo2 is not detecting readings correctly.The customer reported the device was in clinical use, however, there was no report of patient or user harm.The field service engineer (fse) evaluated the incident and advised caller to perform pvt flow testing as well as oxygen mix test to determine if flow sensor may be faulty.Caller stated that he has not performed testing, however he believes the flow sensor is faulty and requested part number.Further information is pending.

Manufacturer Narrative

Insufficient information is available to determine the resolution of the reported event.The customer was provided with the part id for flow sensor assembly; however, it could not be confirmed if the customer replaced the specified part.Multiple good faith efforts (gfe) were performed for further details regarding the event; however, no response was provided.No parts were returned for failure investigation.If additional information becomes available at a later date, 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: 13086275
• MDR Text Key: 282778155
• Report Number: 2031642-2021-05881
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• 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: Health Professional
• Reporter Occupation: Biomedical Engineer
• 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: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 05/21/2022
• Date Device Manufactured: 03/19/2015
• 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