MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problem Device Sensing Problem (2917)

Patient Problems Dyspnea (1816); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  Injury  

Event Description

Philips received a complaint by the customer on the v60 indicating that the proximal pressure sensor alarm had begun to sound.The device was in use on a patient at the time the reported issue was discovered.Clinical assessment performed based on the information currently available in the complaint record.It was reported that ¿patient was brought up from the ed on a v60 plus bipap machine.Once patient arrived to ccu, the ed rt stated the proximal pressure sensor alarm had begun to sound.The ed rt changed to proximity line, but this did not help.Once nurse arrived at patient's room, it was noticed as an equipment malfunction alarm and not something we would be able to troubleshoot ourselves.A new v60 was brought to patient's room and the patient was placed on new machine.The patient experienced an increased work of breathing along with an increased respiratory rate.¿ the patient¿s increased work of breathing and increased respiratory rate represents a change in clinical condition.The clinicians then brought a new ventilator which presumably addressed this change of clinical condition.

Manufacturer Narrative

H10: based on the information provided in the report by the voluntary submitter, the v60 product is not available for evaluation.The report that was sent provides all the information that the fda is allowed to release about the report in question.Multiple attempts have been made to try to obtain further information about this case but no response received from the customer.No further information was able to be obtained.As the v60 product is not available for evaluation, by a manufacturer's product support engineer (pse), it could not be determined if it failed to meet specifications.No additional details regarding the reported issue and its resolution are available.The investigation concludes that no further action is required at this time.If the decision is made to have the device evaluated and repaired a new service order will be opened and will be captured through philip's normal complaint procedure.

• Brand Name: RESPIRONICS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 16975784
• MDR Text Key: 315690784
• Report Number: 2518422-2023-11879
• 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: Other
• Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 07/17/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female