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

Model Number V60 V60PLUS VENTILATOR

Device Problem Inaccurate Delivery (2339)

Patient Problems Hypoxia (1918); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the customer on the v60 indicating that in the process of using the ventilator, the display screen gave an alarm, indicating that the ventilate tidal volume was abnormal, which affected the use of treatment, and the blood oxygen of the patient dropped to 91%.Considering that it might lead to hypoxemia, the ventilator was immediately replaced, and the blood oxygen was measured at 95%.No other clinical information was reported.The investigation on going.

Manufacturer Narrative

E1: (b)(6) hospital.

Manufacturer Narrative

H10: per good faith effort response, it was confirmed the device was being used to treat the patient¿s low oxygen levels.The patient was also connected to an oxygen source, although the requested prescribed o2 levels and ventilatory status of the patient were not provided.The customer also did not provide the final outcome of the patient; however, they did report that a cause for the abnormal tidal volume was determined and ¿after the gas delivery system was replaced by the equipment department, the equipment was restored to normal use.¿ the customer confirmed there were ¿no injuries,¿ therefore the reported harm does not qualify as a serious injury.The engineering department replaced the gas delivery system (gds) to resolve the reported issue.The device passed required performance verification tests per philips standards and was returned to service.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.No further information was able to be obtained.

• 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: 17836491
• MDR Text Key: 324507812
• Report Number: 2518422-2023-24842
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838025776
• UDI-Public: 00884838025776
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• 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 V60PLUS VENTILATOR
• Device Catalogue Number: 1076716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/27/2023
• Date Device Manufactured: 02/09/2017
• 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