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

Model Number V60

Device Problem Excessive Heating (4030)

Patient Problems Unspecified Respiratory Problem (4464); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2021

Event Type  Injury  

Event Description

It was reported that the blower temperature was high.The unit was in clinical use at the time of the event, no patient or user harm reported.Per the diagnostics performed by the engineer, he claimed that the system overheated.The biomed stated that the unit had been running for about seven hours with no issues while using a patient circuit and test lung.The biomed verified that there was an error code 1122 in the significate log.It was reported that the white air inlet filter was very dirty and had a blanket of dust on it.The biomed replaced the inlet filter and verified the cooling fan was operating.The biomed planned to have the unit run all night and test the unit in the morning.The customer stated the unit had been running for many hours and no further problems were found.The unit was very cool and not warm.The customer tested the unit and it passed successfully.The unit was sent back to respiratory for patient use.

Manufacturer Narrative

H11:b5: philips was notified that the hospital's v60 ventilator had experienced a blower temperature high alarm (error code 1122).It was reported that the ventilator had been set up to provide the patient with 60 breaths per minute (bpm).The ventilator was reported to have been in use for eight hours when the blower temperature high alarm occurred.The patient was then transferred to a replacement v60 ventilator (rental) to continue therapy (also set up for 60 bpm).During the four hours of use provided by the replacement v60 ventilator, the unit then displayed the same issue that was initially reported (blower temperature high alarm).The allegation of malfunction reported for the replacement v60 ventilator was documented under complaint mfr report# 2031642-2022-00293 the unit was in clinical use at the time of the event.It was reported that while in use, the patient was breathing/fighting against the ventilator (including thrashing & restlessness).The patient was then intubated, sedated and placed on a icu type ventilator.Based upon the information provided, it is currently unclear as to the sequence of events and whether the patient escalation of care and adverse event occurred while receiving therapy via the original v60 or the backup v60 ventilator.Further investigation into the patient sequence of events, contextual usage, and patient outcome are pending.H10: per the details provided within the servicemax record ((b)(4)), the biomed claimed that the system overheated.The biomed stated that during evaluation, the unit had been running for approximately seven hours with no issues, while using a patient circuit and test lung.The biomed confirmed that error code 1122 was listed in the significate log.It was then reported that the white air inlet filter was very dirty and had a blanket of dust on it.During follow up with the biomed, it was reported that a visual inspection had been completed, and noted that the visual inspection was "very good".The biomed inspected the main filter located behind the side panel, and noted that the filter was very dirty (to the point of almost looking blocked with dust).The biomed reported that both filters were replaced on the their unit, and a full simulation setup was performed using a michigan instrument (mi) computerized test lung.The unit was tested for six hours (under a normal condition, at a rate of 12 bpm).The biomed then confirmed that no failures were observed and the unit operated under normal temperatures.Additional testing was performed, using the ventilator's max setting of 60 bpm, and 100% o2.It was reported that the unit was tested for 17 hours with no faults/errors.The biomed noted that all the tracking data information (flows, timing, internal temperatures) were within specification.The biomed performed a final test, and removed the mi test lung; a normal patient setup was completed, using a drager mp02400 1000 ml self test lung, at a rate of 15 bpm for 6 hours.The biomed reported that no faults or errors were observed.The unit was returned to service without any further issues.

Manufacturer Narrative

Per the diagnostics performed by the engineer, they claimed that the system overheated.The biomed stated that the unit had been running for about seven hours with no issues while using a patient circuit and test lung.The biomed verified that there was an error code 1122 in the significant log.It was reported that the white air inlet filter was very dirty and had a blanket of dust on it.The biomed replaced the inlet filter and verified the cooling fan was operating.The biomed planned to have the unit run all night and test the unit in the morning.During follow up with the biomed, the following details were documented, "ventilator was setup for 60 breaths per min (bpm) this unit running 60 bpm for 8 hours when alarmed occurred.The replacement v60 ran for four hours at 60 bpm when its alarm occurred.Much of this information i found out later during my investigation.I transported the v60 to my shop, i completed a very good visual inspection, i inspected the main filter located behind the side panel.The filter was very dirty and to the point of almost looking blocked with dust, i replaced both filters on the unit.I completed a full simulation setup using a michigan instruments computerized test lung.I ran the unit for 6 hours under a normal condition at 12 breaths per min with no failures and noted normal operating temperatures with inside the v60.My next setup i set the v60 at max 60 breaths per min 100% o2.I ran the test for 17 hours, again no faults or errors, all tracking data information flows, timing etc.Including internal temperature was all in specs.My final investigation and thoughts to the overtempt issue very much could have been caused by the very dirty air filter, also that was noted to me was that the patient was breathing fighting against the ventilator, including thrashing & restlessness.The patient was then intubated, sedated and placed on a icu type ventilator.On my final test i removed the mi test lung and completed a normal patient setup using a drager mp02400 1000 ml self-test lung at 15 breaths per min for 6 hours with no faults or errors.I then returned the v60 back in use.Since then on my follow up with respiratory this v60 has been used on other patients with no issues." per the good faith effort (gfe) response, the issue could not be duplicated after replacing the dirty air filter.The customer stated the unit was running for many hours and no further problems were found.The unit was very cool and not warm.The customer tested the unit and it passed successfully.The unit was sent back to respiratory for patient use.

• 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: 13238552
• MDR Text Key: 287698036
• Report Number: 2031642-2022-00138
• 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,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: 12/20/2021
• Initial Date FDA Received: 01/12/2022
• Supplement Dates Manufacturer Received: 12/30/2021; 12/30/2021
• Supplement Dates FDA Received: 01/24/2022; 01/28/2022
• Date Device Manufactured: 11/06/2017
• 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): Life Threatening