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

Model Number V60

Device Problems Failure to Power Up (1476); Unexpected Shutdown (4019)

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

Event Date 11/21/2020

Event Type  Death  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 07dec2020.

Event Description

A customer reported to philips that while in use on a patient, the respironics v60 ventilator shutdown, hospital staff was not able power the ventilator back on, and the patient required medical intervention that included cardiopulmonary resuscitation efforts, an intubation procedure, and invasive ventilation therapy.This reporter stated that a patient of unknown age, gender, height, and weight was admitted to a hospital on an unknown date with the admitting diagnosis not reported.No relevant medical history or relevant past drug history were reported.Relevant concomitant medical products included cardiac monitoring; prescription and devices not reported.While admitted on an unknown date, the patient was prescribed ventilation therapy via the respironics v60 ventilator; prescription, device settings, configuration, patient circuit, and patient interface not reported.While admitted on (b)(6) 2020, the patient was receiving therapy via the v60 device, when the cardiac monitor and peripheral capillary oxygen saturation monitor alerted hospital staff that the patient experienced an event of bradycardia; beats per minute not reported, and oxygen desaturation; laboratory values not reported.Hospital staff then found the ventilator shut down, the device would not power back on, and the patient required medical intervention that included cardiopulmonary resuscitation efforts and an intubation procedure and mechanical ventilation; tube placement, ventilator brand and model, and prescription not reported.It is unknown if the v60 generated any audible or visual alarms.No relevant laboratory data was reported.On an unknown date, the patient experienced an outcome of death.The cause of death was not reported.

Manufacturer Narrative

G4: 08jan2021.B4: 11jan2021.This reporter stated that this 83 years old male patient with unknown height, and weight was admitted to a hospital¿s intensive care unit on an unknown date with an admitting diagnosis coronavirus (covid-19) and pneumonia.Relevant past medical history included hyperlipidemia and hypertension; diagnostic dates not reported.No relevant past drug history was reported.Relevant concomitant medical products included cardiac monitoring; prescription and devices not reported.The bilevel positive airway pressure (bipap) therapy was initiated on (b)(6) 2020 at 0700.The device settings were as follows: mode not reported, inspiratory positive airway pressure (ipap) 16 centimeters of water (cmh2o), expiratory positive airway pressure (epap) 8 cmh2o, fraction of inspired oxygen (fio2) 100%, no heated humidifier, with an interface of ffm; details not reported.While receiving therapy via the v60 ventilator on (b)(6) 2020 at 1400, the ventilator exhibited a black screen with no display, no audible or visual alarms were generated, the patient experienced an event of bradycardia with a heart rate of 44 beats per minute and severe hypoxia with a peripheral capillary oxygen saturation (spo2) of 32%.Post successful resuscitation efforts, the patient was intubated, manually ventilated, and then placed on a drager v500 ventilator; prescription not reported.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.

Manufacturer Narrative

G4: (b)(6) 2021.B4: (b)(6) 2021.Philips repair bench technician evaluated the device and was unable to duplicate the symptom.Review of the provided diagnostic report from the reported occurrence date of (b)(6) 2021, showed that the device generated a running on internal battery (1212) alarm at 06:25.39 am, a low internal battery (1204) alarm at 12:59.47 pm, and a power has been restored (1218) alarm at 01:12.13 pm and at 02:04.41 pm.No error codes were generated.The reporter stated that the v60's ac power cord was not completely plugged into the ac power outlet.The device ran on internal battery for over six hours before generating the low internal battery (1204) alarm.Approximately 13 minutes later, the power has been restored (1218) alarm was generated.The internal lithium-ion battery has a run-time of at least six hours under normal conditions and provides operating power when ac power is not available.In a low battery condition, the battery can provide operating power for only an additional 15 minutes under nominal conditions.The alarm auto resets when ventilator is connected to ac power (respironics v60/v60 plus ventilator, service manual, publication number 1049766, revision k, 2019, page 34).No parts were replaced.The device passed all performance verification tests.Post device evaluation, the technician performed a yearly preventative maintenance on the device, and then the device was returned to the customer.There was no malfunction of the device.The device was behaving as intended when it alerted the user to a low battery condition, the user did not plug the ac power mains correctly into the ac power outlet, the device then continued to operate for approximately an additional 13 minutes on dc power, and then shut down due to being depleted of dc power.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.

Manufacturer Narrative

Based upon the information provided, no malfunction or failure of the device was discovered during investigation.No failure to perform to manufacturer declared specifications was noted.Due to the unintentional use-error of failure to connect the v60 ventilator to an ac mains power source resulted in a premature cessation of positive pressure therapy and subsequent patient outcome.No causal relationship of the v60 ventilator performance to the patient outcome is noted, however due to the unintentional foreseeable use-error noted, the clinician failure to properly interact with the device has resulted in contribution to the patient outcome.

• 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): PHILIPS MEDICAL SYSTEMS; carlsbad CA
• Manufacturer Contact: bill cole ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 10960816
• MDR Text Key: 220002849
• Report Number: 2031642-2020-04416
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/16/2022

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 11/23/2020; 11/23/2020; 03/08/2022
• Supplement Dates FDA Received: 01/11/2021; 04/19/2021; 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2017
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.; UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Outcome(s): Life Threatening; Death