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

Model Number V60

Device Problems No Display/Image (1183); Failure to Power Up (1476)

Patient Problems Death (1802); Respiratory Distress (2045)

Event Date 07/27/2020

Event Type  Death  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 20aug2020.

Event Description

A customer reported via a user facility medwatch report that while delivering bilevel positive airway pressure (bipap) therapy to a patient, the v60 ventilator¿s screen ¿had gone black¿, and the hospital staff was unable to restart the ventilator.The customer reported that the device was in use on a patient at the time of the reported device behavior, and at the time of the reported adverse event.The patient went into respiratory distress and was intubated and transferred to the icu where the patient expired.

Manufacturer Narrative

G4: 24sep2020.B4: 25sep2020.The device was evaluated by the hospital's clinical engineering department, where the device and power cord was evaluated, working, and plugged into a red power outlet.The reported issue was confirmed and traced to the device operating on battery power for five hours prior to the reported device behavior.No parts were replaced.The device passed all performance assurance tests and was placed back into use with the customer.This reporter stated that an 82 years old female patient born on (b)(6) 1937, weighing 78.1 kilograms with an unknown height, was admitted to a hospital on (b)(6) 2020, with an admitting diagnosis of viral syndrome.No relevant medical history, relevant past drug history or relevant concomitant medical products were reported.While admitted on an unknown date, the patient was prescribed bipap therapy via the respironics v60 ventilator; prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on (b)(6) 2020 at 0600, the patient¿s nurse entered the patient¿s room and noted the v60¿s screen ¿had gone black¿, the hospital staff was not able to restart the device, the patient was then placed on a non-rebreather mask as they were going into respiratory distress, the patient then became unresponsive, a ¿blue alert¿ was called, and the patient was intubated and admitted to the intensive care unit (icu).On (b)(6) 2020, the patient experienced an outcome of death.No relevant laboratory data was reported.The cause of death was not reported.Review of the received diagnostic report (drpta) showed that the device was powered on (b)(6) 2020 at 00:41:01 and passed the speaker powered-on self test (post).At 00:41:09, the device generated an alarm message ¿running on internal battery¿.At 05:33:34 and 05:34:14, the device generated a ¿low internal battery¿ alarm.At 05:47:29, the device generated a ¿low tidal volume¿ alarm.At 05:59:10, the device generated a ¿power restored¿ message.At 05:59:23, the device generated a ¿patient disconnect¿ alarm.At 06:10:58, the device generated a ¿power restored¿ message.At 06:11:00, the device generated a ¿system startup¿ message.At 06:14:54, the device generated a ¿system shutdown¿ message.At 06:56:29, the device generated a ¿system startup¿ message.At 06:57:26, the device generated a ¿power restored¿ message.At 06:57:27, the device generated a ¿system startup¿ message.At 06:57:38, the device generated a ¿patient disconnect¿ alarm.At 06:57:47, the device generated a ¿system shutdown¿ alarm.At 07:09:41, the device generated a ¿system startup¿ message.At 07:09:52, the device generated a ¿system shutdown¿ alarm.Battery can provide operating power for only an additional 15 minutes under nominal conditions.Autoresets when ventilator is connected to ac power (respironics v60/v60 plus ventilator, service manual, publication number 1049766, revision k, 2019, page 100).Power is restored following loss of power.The ventilator restarts and continues ventilation in the mode set before power was lost (respironics v60/v60 plus ventilator, service manual, publication number 1049766, revision k, 2019, page 103).Based on the information captured within this safety report, this v60 ventilator was being used on a patient on battery (dc) power approximately 4 hours and 57 minutes before generating a ¿low internal battery¿ alarm.The device then ran approximately for an additional 26 minutes before shutting down.The approximate total run time on battery power during this reported device behavior and patient event was approximately 5 hours and 23 minutes.The lithium ion battery has a run-time of at least hours under normal conditions, recharges in approximately 5 hours, and has a recommended replacement of every 5 years based on the date of manufacture recorded on the battery label (respironics v60/v60 plus ventilator, service manual, publication number 1049766, revision k, 2019, page 34).There is no information to support that a malfunction occurred.The device was behaving as intended when it alerted the user to a low battery condition.The "low internal battery" message is an expected device behavior when the device is operating on battery power and has approximately 15 minutes of power remaining on dc power.The root cause is traced to user error.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: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 10432901
• MDR Text Key: 203736808
• Report Number: 2031642-2020-02860
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

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: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.; UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Weight: 78