MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR

Model Number V1000

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 11jul2020.

Event Description

A user facility reported to the fda via medwatch mw5093980 the a respiratory therapist had to manually ventilate a patient while a replacement ventilator was obtained, due to a v100 ventilator powering down by itself.The customer reported that no patient harm occurred.

Manufacturer Narrative

G4: 06oct2020, b4: 07oct2020.The manufacturer's field service engineer confirmed the reported problem.The field service engineer also heard clicking from the power supply, as well as bus voltage moving between 29 and 21 volts (manufacturer¿s report number 2031642-2020-01190).The manufacturer's field service engineer replaced the backup battery to address and correct this reported condition.The field service engineer also replaced the power supply to address the volt variance and clicking.The device then passed all specifications.The ventilator's power supply was returned to the manufacturer's failure investigation lab for evaluation.Visual inspection of the power supply revealed no evidence of damage and contamination.The power supply was installed into the failure investigation (fi) test ventilator to verify & test its functional integrity.From testing, it was determined that the test ventilator utilized with the returned power supply did not pass testing.The ventilator shut down when alternating current (power from the power supply) was applied.Further testing determined voltage was dropping below the threshold voltage of 8.5 volts, and the "c56" capacitor signal was dropping to 7.11volts (manufacturer¿s report number 2031642-2020-01190).The failure of the capacitor "c56" of the power supply prevented the ventilator from operating on ac power.The information captured pertaining to the evaluation, resolution, and disposition of the device, originated from a report by the customer of a ventilator inoperative condition with no patient involvement that was investigated and reported via manufacturer¿s report number 2031642-2020-01190.This safety report captured the limited information that was received from user facility medwatch report (mw5093980).The customer filed the user facility medwatch after they requested philips technical support (manufacturer¿s report number 2031642-2020-01190).Both reports are related and are associated to the same event.A philips clinical post market specialist contacted the user facility many times, but the hospital did not provide any details about the event of the patient being manually ventilated due to a v1000 ventilator powering down by itself.No adverse event was reported or associated with the use of the device.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ESPRIT VENTILATOR
• Type of Device: VENTILATOR
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 10261777
• MDR Text Key: 198478987
• Report Number: 2031642-2020-02316
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K981072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

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: V1000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/11/2020
• Supplement Dates Manufacturer Received: 07/01/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER