MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problems Defective Alarm (1014); Output below Specifications (3004)

Patient Problems Bradycardia (1751); Death (1802); Low Oxygen Saturation (2477)

Event Date 08/08/2018

Event Type  Death  

Manufacturer Narrative

Date of report: 09/10/2018.The biomedical engineer checked the error codes and no vent inoperable/check vent codes were found and observed a 2002 code indicating the vent was powered off.The philips field service engineer (fse) completed a performance verification test on the ventilator and could not confirm or duplicate the reported issue.The fse inspected the event logs and found no error codes for standby and vent inoperable for the time of the reported event.The ventilator successfully passed testing by the philips fse and there were no parts replaced.

Event Description

The customer reported that the nurse and respiratory therapist were outside the room while a portable chest x-ray was being performed on the patient.The monitor technician called out that patient¿s oxygen saturation was dropping.The nurse and therapist entered the room and the therapist noted that the v60 ventilator in bipap mode was ¿on stand-by¿.No audible alarms were heard by any team members.The mask was immediately removed and ambu bag utilized.The patient became bradycardic and expired a short time later.The hospital biomed reported that the issue with the ventilator is not thought to have contributed to the patient death.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): RICA; 2271 cosmos court; carlsbad CA 92011
• Manufacturer Contact: lisa cardenas ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 7861168
• MDR Text Key: 119717125
• Report Number: 2031642-2018-01840
• 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: K082660
• 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
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2012
• 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
• Patient Age: 86 YR
• Patient Weight: 72