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 Cyanosis (1798); Dyspnea (1816)

Event Date 10/05/2021

Event Type  Injury  

Event Description

It was reported that during therapeutic use of the v60 ventilator, an error code of 110d (proximal pressure range error) had occurred.Additionally, it was stated that the device did not produce an alarm when the breathing circuit was disconnected.Further investigation is pending to clarify the problem with the customer.The device was in clinical and therapeutic use at the time of the reported event.The patient is noted to have been cyanotic.Further investigation is currently pending.The device was evaluated and investigated by the institutional biomedical engineer.The diagnostic report was retrieved and forwarded to philips and performance verification testing (pvt) conducted in addition to device run-in testing for approximately 8+ hours.Diagnostic report analysis confirmed a solitary occurrence of the 110d error code.Pvt was conducted with no fault found and verification of the devices ability to perform to manufacturer declared specifications.Additional verification testing confirmed audible and visual alarms for both patient disconnection and proximal pressure line disconnection alarms.The device has subsequently been released and returned to full clinical service with no fault found.

Manufacturer Narrative

Further investigation has discovered the device was in clinical use providing therapy to a covid positive patient in an isolation room at the time of the event.The patient had become disconnected from the breathing circuit (non-philips product) and began audibly calling for clinical assistance.Upon discovery of the disconnection, the institutional clinician had found the patient exhibiting dyspnea and mild cyanosis.The patient was manually ventilated and subsequently placed back onto the device.No further harm or injury had been noted.Further investigation has determined that the device functioned as designed with no failure or malfunction noted by the institutional biomedical engineer.Due to the disconnection of the breathing circuit (non-philips product) from the v60 device outlet port, the patient experienced dyspnea and mild cyanosis resulting in the need for medical intervention via manual ventilation until the device was reconnected to the patient.

• 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: 12634261
• MDR Text Key: 276453573
• Report Number: 2031642-2021-05292
• 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: Health Professional
• Reporter Occupation: Biomedical Engineer
• 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?: 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?: Yes
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 11/17/2021
• Date Device Manufactured: 01/09/2021
• 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