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

Model Number V60

Device Problems Defective Alarm (1014); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 11mar2021.

Event Description

It was reported to philips that the device did not alarm when the patient became disconnected from the patient circuit.The device was in use at the time of the event.There was no report of patient or user harm.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer confirmed the settings.The rse advised the customer to begin performing the performance verification testing to determine if there are any issues with the ventilator.Additional information was requested from the rse who reached out to the clinical contact at the facility.

Manufacturer Narrative

G4: (b)(6) 2021.B4: (b)(6) 2021.The device was in use at the time of the event.The disconnect was between the mask and the circuit.The patient was changed to another v60 with a new circuit filter and mask.There was no report of patient or user harm.The device was evaluated by the hospital's biomed with assistance from a philips remote service engineer (rse).The customer confirmed the settings.Mode: s/t high rate: 40 bpm; ipap: 13 cmh2o low rate: 10 bpm; epap: 4 cmh2o hi vt: 900 ml; rate: 24 bpm lo vt: 85 ml; i-time: 1.00 sec hip: 35 cmh2o; rise: 3 lip: 4 cmh2o; ramp: off low ve: 3.0 l/min; o2: 21% lip t: 20 sec.The therapist reported after the unit was removed from the patient that they disconnected the circuit from the mask and it did not alarm.Then they disconnected the circuit from the machine and it still did not alarm.The inspiratory filter was left connected to the front of the ventilator.The type of filter was king systems hepa filter 6159.The customer stated the drpt was reviewed from serial number (b)(6), and there were no instances of any check vent or vent inop codes that would indicate any type of failure with the equipment.The rse instructed the biomed to perform the performance verification testing (pvt) to determine if there are any issues with the ventilator.The biomed reported back to the rse that the ventilator has passed the pvt with no issues.The rse advised the customer once filter and circuit is installed on set up to ensure that the disconnect alarm works with the filter in use.The rse also discussed setting the secondary alarms tighter.A good faith effort was made to the customer who stated no parts needed to be replaced, and it was confirmed that the alarm functions were all working as specified when checked during the pvt.Review of the device event log indicates that the alarm audio volume was set to the highest volume (setting of 10) on (b)(6) 2021, 4 days prior to the reported incident date of (b)(6) 2021.Two occurrences of patient disconnect alarm along with one occurrence of proximal pressure line disconnect alarm were recorded in the event log on the date of incident.The customer's alleged malfunction was not confirmed via performance verification testing (pvt) or through review of the drpt.The biomed verified the device audible alarm functionality.Review of the drpt confirms that the unit appropriately annunciated disconnection alarms at the time of the reported event.Based on this evaluation results, it can be concluded that the device functioned as intended and there was no malfunction.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: 11467179
• MDR Text Key: 242581308
• Report Number: 2031642-2021-00930
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/11/2021
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2011
• 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