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

Model Number V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+

Device Problem Excessive Heating (4030)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2021

Event Type  malfunction  

Event Description

It was reported to philips that while in clinical and therapeutic use the v60 ventilator displayed an error message stating "blower temperature too high." specific error code generated currently has not been provided to philips and is pending further investigation.The device was in clinical and therapeutic use at the time of the event.Patient identified demographics have not been provided to philips.The patient condition was noted to have been end-stage with poor prognosis and a respiratory rate of approximately 55 breathes per minute.During the event in question, the device provided an audible and visual alarm at approximately 1200 on (b)(6) 2021.At approximately 1230 a medical engineer arrived with a replacement device, to which the patient was transitioned to the backup ventilator (philips v60).The patient remained on therapy via the v60 ventilator until approximately 1430 on (b)(6) 2021 when they were noted to have expired.No harm or injury during or after the alleged ventilator malfunction and device transition has been noted.

Manufacturer Narrative

The device has been inspected preliminarily, with no recurrence of the blower temperature too high alarm has been noted.The cause and/or contribution of the v60 ventilator and further investigation is currently pending.(b)(6).

Manufacturer Narrative

Based upon new information received, this complaint record shall be downgraded to a product problem complaint.No cause and/or contribution of the v60 ventilator to the patient outcome was noted, with testimony provided by the institution that the patient desaturation of peripheral oxygenation and subsequent death were caused by a decline in patient condition.Further investigation efforts discovered that during clinical and therapeutic use of the device, the patient was noted to have been in poor prognosis with a spontaneous respiratory rate greater than 50 breathes per minute and a saturation of peripheral oxygenation (spo2) of approximately 70%.Upon the triggering of the blower temperature high alarm on the v60 ventilator (sn (b)(6)), the patient was removed from the ventilator and placed onto a backup v60 ventilator (sn unspecified) with the same therapeutic settings.The patient was noted at that point to have decreased in respiratory rate with a monitored spo2 of approximately 60%.The patient subsequently expired approximately 1.5 hours after being placed onto the backup v60 ventilator.Clinical assessment provided by the institution has determined that due to the patients rapidly declining condition prior to the occurrence of the blower temperature high alarm, no cause and/or contribution of either v60 ventilator (sn (b)(6)) or the backup v60 ventilator (sn unspecified) to the patient outcome exists.60 ventilator (sn (b)(6)) is currently pending further evaluation to determine the cause of the blower temperature high alarm.It was noted that during the event in question, the v60 ventilator did not stop providing therapy to the patient.No allegation of malfunction has been lodged in relationship to the backup v60 ventilator (sn unspecified).

Manufacturer Narrative

The ventilator software version is 2.30.There is no further information on the cause of death as the patient's baseline condition was already in poor clinical state at the time of the of the initiation and clinical use of the v60 device.Blower temperature high error (diagnostic code 1122) was confirmed in the event log.A test run was performed on (b)(6)2022 and the reported issue was not duplicated.As per the customer's request, repair was not performed, and the unit was returned.

• 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: 13121464
• MDR Text Key: 282994854
• Report Number: 2031642-2021-05916
• 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,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?: Yes
• Device Operator: Health Professional
• Device Model Number: V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/26/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 02/07/2022; 05/05/2022
• Supplement Dates FDA Received: 03/08/2022; 05/09/2022
• Date Device Manufactured: 03/18/2014
• 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