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

Model Number V60 V60PLUS VENTILATOR

Device Problem Gas/Air Leak (2946)

Patient Problems Hypoventilation (1916); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2023

Event Type  Injury  

Event Description

Philips received a complaint by the customer on the v60 indicating that due to the customer reporting a patient admitted to the hospital for an acute exacerbation of copd (type ii respiratory failure) was using the device in st mode and reported chest tightness.It was subsequently noticed that the patient¿s pco2 had increased compared to the day prior.The patient was then switched to an alternative v60 ventilator with adjusted vent parameters and the patient¿s pco2 ¿significantly decreased¿ compared to the prior two days and the patient no longer complained of chest tightness.The customer stated ¿patients using the ventilator can only inhale, cannot exhale, suspected to be related to the product.The investigation is ongoing.

Manufacturer Narrative

Information was received that at 8:32 on (b)(6) 2023, the patient was admitted to the hospital with "chronic cough and sputum production for more than 30 years, aggravation with edema for 5 days", and was diagnosed with chronic obstructive pulmonary disease with acute exacerbation type ii for respiratory failure, chronic cor pulmonale, etc.An allegation of increased patient pco2 was noted.Values of arterial blood gases taken state the following: admission abg: ph 7.339, po2 92mmhg, pco2 81.6mmhg on fio2 of 29 l/min approximately 54 hours later status-post niv (settings not provided) with exhalation difficulty noted ph 7.293, po2 72mmhg, pco2 97.5mmhg the partial pressure of carbon dioxide increased compared with the previous day, and the patient was immediately switched to another v60 ventilator and adjusted the ventilator settings titration conducted: ipap 19cmh2o, epap 5cmh2o, i/e 1:2.3, fio2 30% the patient did not have chest suffocation, and the blood gas analysis was rechecked on (b)(6) ph 7.371, po2 73mmhg pco2 was 55.9mmhg, exhalation difficulty noted.While the patient was transferred to another device, it was confirmed that there was no adverse reaction to the patient nor a delay.No further information was able to be obtained regarding the device diagnostic report and device troubleshooting.It was confirmed that the device successfully passed performance specification testing after the repair was completed and the device is back in service.No parts were replaced.Updated: b1, b2, h1, patient outcome code grid, health impact grid.

• 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: 18163122
• MDR Text Key: 328968017
• Report Number: 2518422-2023-30992
• 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: 11/08/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 02/01/2024
• Date Device Manufactured: 06/03/2020
• 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