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

Model Number V60

Device Problem Use of Device Problem (1670)

Patient Problem Bradycardia (1751)

Event Date 06/04/2021

Event Type  Death  

Manufacturer Narrative

Reported: 11jun2021.(b)(4).

Event Description

On (b)(6) 2021, a patient was receiving positive pressure ventilation via the v60 ventilator.The patient was hyper-oxygenated and removed from the ventilator by a registered nurse (rn) during a nasogastric tube placement procedure.During this period the patient was noted to have a saturation of peripheral oxygenation of 91% and a noted respiratory rate of approximately 30 breathes per minute.It was stated that the rn had to leave the room and handed the non-invasive interface to an accompanying rn to reinitiate positive pressure ventilation.The accompanying rn placed the interface on the patient and noted audible air flow from the device.Facility ventilator case reports state the accompanying rn did not verify efficacious therapy delivery of flow, pressure, and monitored tidal volumes via the v60 ventilator.Approximately 2 minutes later the patient heart rate dropped from approximately 70 beats per minute to 40 beats per minute.A medical doctor (md) checked for palpable pulse and noted that the v60 ventilator screen stated the device was in standby mode and therapy was not delivered.An institutional code was called and the patient subsequently expired.The device was in clinical/therapeutic use at the time of the event.The patient was noted to be (b)(6) years of age, female, with primary diagnosis of left-sided weakness.No further patient information or demographics have been disclosed at this time.The device was returned to the distributor and inspected by a philips field service engineer (fse).Device diagnostic report logs were retrieved and reviewed by the fse and sr.Clinical post market specialist with no malfunction or errors noted during the time of the event in question.The device underwent performance verification testing as per philip service procedures with no malfunction or failure to meet manufacturer declared specifications found.No parts or repair has been initiated or required regarding this case.The device has subsequently been released for clinical use.

Manufacturer Narrative

B4: 15jul2021.Further investigation has found primary diagnosis of the patient to be status-post cerebrovascular accident - ischemic stroke, with decreased airway protective mechanism, aspiration risk, and diminished inspiratory capabilities.Based upon further information received by the clinical end-user, the customer has refuted any allegation of device malfunction and states device check was requested for verification that no faults, failures, or malfunctions were noted.The customer has been provided copies of the device diagnostic reports and performance verification testing transcripts.No causal relationship has been identified between the v60 ventilator and the patient outcome, however due to foreseeable use error of this nature, contribution cannot be ruled out.The use-error has been identified by philips and addressed within the v60 ventilator user guide: use the respironics v60/v60 plus ventilator on spontaneously breathing patients only.It is an assist ventilator and is intended to augment the ventilation of a spontaneously breathing patient.It is not intended to provide the total ventilatory requirements of the patient.

Manufacturer Narrative

Health impact code is updated.

• 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: 11987052
• MDR Text Key: 255791977
• Report Number: 2031642-2021-04053
• 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

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: 06/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2021
• Supplement Dates Manufacturer Received: 06/15/2021; 05/20/2022
• Supplement Dates FDA Received: 07/15/2021; 05/21/2022
• Date Device Manufactured: 10/11/2018
• 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: 95 YR
• Patient Sex: Female
• Patient Weight: 51 KG