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

Model Number V60

Device Problem No Flow (2991)

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

Event Date 11/14/2023

Event Type  malfunction  

Event Description

Philips received a complaint by the biomedical engineer (bme) on the v60 indicating that the device intermittently did not display o2.The device was in use on a patient at the time the reported issue was discovered; however, there was no harm to the patient or user.The biomedical engineer (bme) reported to the remote service engineer that the device intermittently did not display o2.The bme also explained that the device was used on e cylinder tanks and requested onsite service.The rse informed the customer that a quote would need to be approved with a purchase order (po) number for a field service engineer (fse) to be dispatched onsite.The bme mentioned to the rse that field correction order (fco) was recently implemented a couple of weeks ago, but it should have nothing to do with this incident.The bme also informed the rse that the flow sensor assembly was replaced prior to fco.The rse created an onsite work order (wo) for repair.The investigation is ongoing.

Manufacturer Narrative

After repair by philips, the bme reported to the rse that the patient desaturated because the device indicated "no o2" even though 2 o2 cylinders were swapped twice.The bme requested to have the device evaluated.The rse created an onsite wo for a philips service engineer to be dispatched.An authorized service provider (asp) was dispatched onsite to evaluate and repair the device.Upon arrival, the asp completed the air/o2 mixture test with the manifold and tanks with passing results, but the manifold was found to be defective-- when disconnecting the tanks, the valve did not close properly.The device passed the full preventive maintenance (pm) with wall o2.Pending onsite service for repair.

Manufacturer Narrative

The authorized service provider (asp) stated that the biomedical engineer (bme) reported that the device was giving a 1208 "oxygen not available" alarm error message.The bme informed the asp that the device was tested, and the issue could not be duplicated; however, since the issue occurred while in use, the bme wanted the asp to evaluate and repair the device.The asp performed a full performance verification test (pvt) on the device and was unable to duplicate the issue.The rse recommended that the asp confirm operation of the o2 manifold on the back of device and verify that all 3 options, both tanks and wall o2 line, are working properly.Pending onsite service for repair.

Manufacturer Narrative

Upon arrival, the asp completed the air/o2 mixture test with the manifold and tanks with passing results, but the manifold was found to be defective-- when disconnecting the tanks, the valve did not close properly.The device passed the full preventive maintenance (pm) with wall o2.The asp stated that the bme reported that the device was giving a 1208 "oxygen not available" alarm error message.The bme informed the asp that the device was tested, and the issue could not be duplicated; however, since the issue occurred while in use, the bme wanted the asp to evaluate and repair the device.The asp performed a full performance verification test (pvt) on the device and was unable to duplicate the issue.The rse recommended that the asp confirm operation of the o2 manifold on the back of device and verify that all 3 options, both tanks and wall o2 line, are working properly.The asp completed the repair by replacing the o2 transport kit.The device passed the required performance verification tests per philips standard and was returned to service.The investigation concludes that no further action is required at this time.

• 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: 18277608
• MDR Text Key: 329860888
• Report Number: 2518422-2023-33995
• Device Sequence Number: 1
• Product Code: MNT
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,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: Not provided
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 11/22/2023; 12/08/2023; 01/02/2024
• Supplement Dates FDA Received: 12/12/2023; 01/03/2024; 01/08/2024
• Date Device Manufactured: 09/06/2014
• 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