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

Model Number V60

Device Problems Fire (1245); Melted (1385)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported to philips that the respironics v60 ventilator¿s power cord caught on fire and melted the hot and neutral prongs, while delivering non-invasive therapy to a patient.The customer reported that the unit was in use on a patient at the time of the reported device behavior.No adverse event was reported or associated with the use of this device.

Manufacturer Narrative

G4: 04nov2020.B4: 05nov2020.A philips authorized representative evaluated the device.The reported issue was confirmed that the v60's power cord caught on fire, melted the hot and neutral prongs, leaving only the ground terminal intact.Review of the provided photographs of the device's internal parts did not show any signs of fire or smoke damage.The biomedical engineer replaced the power cord.The device passed all performance verification testing and remains at the authorized representative's bench.This risk program manager reported that a white 71 years old male patient, weighing 94 kilograms, with a height not reported, was admitted to a hospital¿s intensive care unit on an unknown date with the admitting diagnosis not reported.Relevant medical history included immunocompromised and pneumonia; diagnostic dates not reported.No relevant past drug history or relevant concomitant medical products were 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 bi-level positive airway pressure (bipap) therapy via the v60 device, the device was plugged into a red emergency backup power hospital receptacle located on the wall behind the patient, at an unknown time from starting therapy approximately three foot flames were produced from the ac power mains where the ventilator¿s power cord was plugged into, hospital staff then attempted to remove the patient from the room but the ventilator was connected to the wall for electricity and oxygen at or near the fire, hospital staff then obtained a fire extinguisher, the fire was extinguished, the power cord and oxygen hose were disconnected from the wall, the patient was safely removed from the room and taken to another room, where hospital staff then placed the patient on another ventilator and therapy continued; brand and model not reported.No adverse event was reported or associated with the use of this device.No relevant laboratory data was reported.The ventilator¿s power cord caught on fire, melted the hot and neutral prongs, leaving only the ground terminal intact.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

G4:23feb2021.B4:24feb2021.H11:g5:k102985.H10: the submitted power cord was received and analyzed by the igt failure investigation lab due to expanded tooling for analysis.Radiographic examination revealed little additional evidence as compared to optical observation: the extent of damage on the wall plug end of the power cord reveals melted amalgams of material, missing hot and neutral prongs, and no further indications of failure along the length of the cord.After multiple attempts to retrieve the wall socket from the hospital that the event occurred with, the socket has not been sent to philips for analysis.Without the information to be learned from the socket side, the root cause of failure cannot be established.Due to the extent of damage on the ac cord, lack of failures identified with the ventilator during post-event service, and missing information from the wall socket, the root cause of this failure cannot be determined.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

G4:17mar2021.B4:18mar2021.This complaint was received via user facility report (b)(4).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
• MDR Report Key: 10687517
• MDR Text Key: 213479384
• Report Number: 2031642-2020-03740
• 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,Followup,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2010
• 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
• Patient Age: 71 YR
• Patient Weight: 94