MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. V60 VENTILATOR

Model Number V60

Device Problem No Flow (2991)

Patient Problems Low Oxygen Saturation (2477); Underdose (2542)

Event Date 12/07/2014

Event Type  Injury  

Manufacturer Narrative

Investigation summary conclusion updated; failure analysis on the power management board found that the 35 volt failure was traced to q14 which was shorted with 0.78 ohms of resistance from the drain pin 2/4 to source pin 3.Replacement of q14 (lot code: 309p) on the pm board corrected the failure.(b)(4).The patient was removed from the ventilator and manually ventilated via resuscitation bag then placed on another ventilator device.The patient's spo2 increased back to 90%.There was no permanent harm to the patient.The manufacturers field service engineer (fse) was able to duplicate the reported problem and found a 35 volt failure in the event log.The fse replaced the power management pcb board to address the reported problem.

Event Description

The international customer reported the ventilator airflow stopped.The customer reported that the unit was in use on patient and patient desaturated.The patient spo2 decreased from 95 to 60%.

Manufacturer Narrative

(b)(4).The patient was removed from the ventilator and manually ventilated via resuscitation bag then placed on another ventilator device.The patient's spo2 increased back to 90%.There was no permanent harm to the patient.The manufacturer field service engineer (fse) was able to duplicate the reported problem and found a35 volt failure in the event log.The fse replaced the power management pcb board to address the reported problem.

• Brand Name: V60 VENTILATOR
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC.; 2271 cosmos ct.; carlsbad CA 92011
• Manufacturer Contact: richa shah ; 3000 minuteman rd.; andover, MA 01810 ; 9786594907
• MDR Report Key: 4417463
• MDR Text Key: 14221756
• Report Number: 2031642-2015-00026
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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): Required Intervention