MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number V60

Device Problem Device Sensing Problem (2917)

Patient Problems Asystole (4442); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/31/2021

Event Type  Death  

Manufacturer Narrative

Report date: 10aug2021.(b)(4).

Event Description

Philips has been notified of an alleged v60 ventilator malfunction whereby the device is claimed to have entered "standby mode" while in use on a patient and providing therapy.The device was in clinical use at the time of the event providing positive pressure therapy to the patient.Due to the alleged malfunction of the v60 ventilator, the patient subsequently expired.The investigation is ongoing.

Manufacturer Narrative

Further investigation has yielded the following patient information: the patient was an 85 year old male (do not resuscitate/do not intubate) admitted on (b)(6) 2021 with varied diagnoses of confusion, diarrhea, and significant cardiopulmonary history including mitral regurgitation and pulmonary hypertension.The patient was prescribed non-invasive bilevel ventilation via the v60 due to a deterioration in condition with a noted ph decrease and unspecified acidosis.During therapy, the patient was removed from the device for administration of p.O.(per os) medication by an attending rn (registered nurse).During this period the device was placed into standby mode.After administration of medication, the patient was placed back onto the v60 ventilator non-invasively while the rn discussed patient care with the attending pa (physicians assistant).The nurse returned to the room and found the patients condition had deteriorated further, noting the device remained in standby mode.Patient vitals were recorded at 2200 (undisclosed spo2).The patient went into asystole and pronounced at 2216.Preliminary investigation of the device was conducted by the institutional biomedical engineer.A drpt (diagnostic report) was retrieved and furnished to philips for review with no error or malfunction noted.The customer has elected to enlist their own third-party biomedical service of the device to conduct pvt (performance verification testing).Further information and evaluation results are pending.

Manufacturer Narrative

Patient outcome and health impact codes were updated based on the previous information submitted.Conclusion and root cause cannot be determined as per the institutional risk manager the device remains sequestered and had no additional information that could be provided.

Manufacturer Narrative

Follow-up information was received from the institutional risk manager who indicated that the ventilator remains sequestered, and had no additional information.

Manufacturer Narrative

The device event log was reviewed by a third-party service engineer (se).There were no events or alarms recorded in the device log that indicate a device malfunction occurred.The customer reported issue of ventilator transitioned to standby mode while in use could not be confirmed.The ventilator was released from sequestration based on the se evaluation.The device was not returned for failure investigation (fi).Based on the service performed and the event log review the device malfunction alleged by the customer was not confirmed.Trends for this type of issue will continue to be monitored to determine if additional actions are required.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 CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 12302013
• MDR Text Key: 265844057
• Report Number: 2031642-2021-04523
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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?: No
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/04/2021
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 09/02/2021; 05/06/2022; 05/16/2022; 11/02/2022
• Supplement Dates FDA Received: 10/01/2021; 05/09/2022; 05/25/2022; 01/17/2023
• Date Device Manufactured: 08/10/2010
• 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
• Patient Age: 85 YR
• Patient Sex: Male