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

Model Number V60

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 05oct2020.

Event Description

It was reported to philips that the device had frozen and was no longer functioning.The device was reported as being in use at the time of the event on a patient.The initial reporter confirmed that there was no adverse patient impact.

Manufacturer Narrative

G4:30dec2020.B4:31dec2020.The removed power management printed circuit board assembly (pm pcba) assembly was returned for analysis.The visual inspection of the touchscreen assembly revealed no evidence of damage or contamination.A failure investigation (fi) technician installed the pm pcba into a fi ventilator to verify and test the functionality.The returned pm pcba was found to have a failure of the solder application at r31.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

A philips field service engineer (fse) was dispatched to the customer site.The reported issue was confirmed.The fse replaced the power management printed circuit board assembly (pm pcba).The device passed performance verification testing.Following the repair, the device was returned to the customer to be placed back into service.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: 04jan2021.B4: 06jan2021.H11: the removed power management printed circuit board assembly (pm pcba) assembly was returned for analysis.The visual inspection revealed no evidence of damage or contamination.A failure investigation (fi) technician installed the pm pcba into a fi ventilator to verify and test the functionality.The returned pm pcba was found to have a failure of the solder application at r31.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: 10631824
• MDR Text Key: 210622531
• Report Number: 2031642-2020-03569
• 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: foreign,user facility
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1622-2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER