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

Model Number V60

Device Problem Failure to Sense (1559)

Patient Problems Bradycardia (1751); Convulsion/Seizure (4406)

Event Date 03/18/2024

Event Type  Death  

Manufacturer Narrative

E1 reporting institution phone number - (b)(6).Reporter phone number - (b)(6).

Event Description

Philips received a complaint indicating that a call from a chief nurse stating the following was received: as the patient's heart rate on the vital signs monitor decreased, they checked the patient's room and found that the v60 had a leak of 100l or more, but circuit disconnection alarm did not sound, and the patient's condition was found to be deteriorated.The sales representative arrived at the hospital and received the following information on the event: as the patient's heart rate on the vital signs monitor decreased, they entered the patient's room and found that the cap to attach the nivo of the elbow of af541 was open and there was a high amount of leak from there.The onscreen leak was more than 100l, but circuit disconnect alarm was not sounding.They closed the cap and retuned the leak to the appropriate amount, increased the fio2 up to 27% as the saturation was dropping and saw how it went.As the patient was experiencing seizures at 20-second intervals, they determined that it was too risky to replace the device at that time and continued using this device.It was noted that the patient has used the device for 18 days.The patient's outcome was noted as ¿not yet recovered as of 3/18¿.It was reported that the patient was able to breathe spontaneously.The sales representative confirmed that the device was operating properly but was unable to test the alarm functionality.He prepared an alternative device so that they can replace it once the patient's condition becomes stable.As the sales representative was unable to retrieve the device, he has not confirmed the reported phenomenon or error records in the diagnostic mode.He will retrieve the device and send it to the repair center once the device is replaced.It was also noted that ¿causal relationship between the device and patient harm: unknown (this is a nurse's observation.)¿ further information has been requested regarding the reported event.A supplemental report will be submitted once more information is provided.

Manufacturer Narrative

Information was received that the patient passed away on (b)(6), 2024, approximately 2 days status post the event in question.It was noted that the product name of the part which got off was a af541 mask l.The overall circuit configuration: 1126411 is disposable passive circuit wtp + pmc300af.The alarm occurred when the circuit got off.The nurse said that circuit disconnect' alarm should have occurred but it didn't, even though the leakage was more than 100l.There were no other occurrences of alarms reported.Per the clinical expert who performed the clinical assessment of this complaint: based upon the information currently provided and available, under the circumstances of unanticipated use error of the interface (access port on mask opened during therapeutic delivery), the device performed as designed.While attached to a spontaneously breathing patient, the patient disconnection alarm is not intended to trigger to alert the clinical end user of exorbitant unanticipated circuit leaks.Therefore, no cause and/or contribution of the device to the patient outcome has been defined.Evaluation and repair of the device is still pending.

Manufacturer Narrative

A good faith effort response received indicated that the sales representative tried to obtain further information from the hospital regarding the additional requested questions of the device settings and configurations, patient spo2 and patient heart rate during the event in question.However, the hospital responded that they were unable to provide any further information.The device was received by the repair center and the technician performed a check.The event log showed that the customer modified the oxygen concentration and respiratory rate a few times after the time of the event.There were no records for the occurrence of errors indicating a failure of the device.There was no abnormality during the functional test.The masks and chambers are still pending arrival for verification.

Manufacturer Narrative

Per a good faith effort response received, it was confirmed that the sales representative tried to obtain further information from the hospital regarding the additional requested questions of the device settings and configurations, patient spo2 and heart rate during the event in question.However, the hospital responded that they don't remember and were unable to provide any further information.The device was received by the repair center and the technician performed a check.The device's event log indicated that the customer modified the oxygen concentration and respiratory rate a few times after the time of the event.There were no records for the occurrence of errors indicating a failure of the device.There was no abnormality during a functional test and are waiting for the masks and chambers to arrive for verification.The technician performed a run-in test and circuit configuration with the setting of use and opened the cap of the nebulizer port for the mask elbow, but the 'patient disconnect' alarm did not sound.It is deemed that the cause of the issue was that resistance occurred in the circuit due to effects of accessory and the tube compliance for the circuit (rt319).There was no abnormality during the inspection.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened and a supplemental report will be submitted.

• 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: 18975353
• MDR Text Key: 338553497
• Report Number: 2518422-2024-15106
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: 00884838033832
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 03/25/2024; 04/01/2024; 04/17/2024
• Supplement Dates FDA Received: 03/28/2024; 04/09/2024; 04/22/2024
• Date Device Manufactured: 05/18/2020
• 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): Death; Required Intervention
• Patient Sex: Female