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

Model Number V60

Device Problems Device Sensing Problem (2917); No Apparent Adverse Event (3189)

Patient Problem Cardiac Arrest (1762)

Event Date 06/20/2022

Event Type  malfunction  

Event Description

A v60 ventilator is reported to have transitioned to stand-by mode autonomously; patient died.This report was received via a customer feedback form from a philips medical leader on behalf of an icu physician.A patient of unknown age and gender who was an inpatient in an intensive care unit (icu), with strict limits to care and had a code status of ¿do not resuscitate" (dnr) and ¿do not intubate" (dni) was on a v60 ventilator (unknown serial number, software version number, settings, and configurations) for an unspecified indication.Approximately one month ago, while the device was in clinical use, the patient went into cardiac arrest and died.The reporter indicated that the ventilator went into standby mode autonomously without generating an alarm.Philips' medical leader did not receive the initial report directly from the treating physician but from an icu physician who was present at the time of the event.Subsequent information was obtained by philips' medical leader from both the treating physician and risk manager who confirmed that based on their investigation there was no ventilator issue or malfunction.It was human error.The full details of the human error were not reported.Based on the information provided, both the physician and risk manager confirmed that there was no device malfunction.Per their investigation, the root cause is attributed to human error.

Manufacturer Narrative

Follow-up information received from the risk manager indicated that there appeared to have some incomplete information provided.Their institution does not have an adverse event to report to philips as they would notify directly.Based on the confirmation received from the risk manager that there was no adverse event, this complaint is being redacted from a death report to a non-complaint.

• 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: kimberly shelly ; 2271 cosmos court; carlsbad, CA 92011 ; 7609187300
• MDR Report Key: 14937641
• MDR Text Key: 295396284
• Report Number: 2031642-2022-01819
• 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: Physician
• 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?: 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: 06/20/2022
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 08/21/2022
• Supplement Dates FDA Received: 08/26/2022
• 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