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

Model Number V60

Device Problem Defective Alarm (1014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 18aug2020.

Event Description

The customer reported to philips that the unit has an alarm led failure.The device was not being used on a patient at the time of the event.A philips service technician checked the error log and confirmed the occurrence of the error an error indicating alarm led failure.

Manufacturer Narrative

G4: 08sep2020.B4: 09sep2020.A philips service technician checked the error log and confirmed the occurrence of the alarm led failure.The reported issue was unable to be confirmed by operational check, however the error associated with the alarm led failure was confirmed in the error log.The philips service technician replaced the power switch overlay to resolve the reported led issue and the device returned to functionality.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

G4:16dec2020.B4:17dec2020.The power switch overlay was returned to the manufacturer for evaluation.Visual inspection of the power switch overlay revealed no evidence of damage or contamination.A failure investigation (fi) technician installed power switch overlay into a fi ventilator to verify the reported problem and test the functionality.The alarm (red) led detached from the trace not making contact on the power switch overlay created the alarm led failed error code.The reported complaint was confirmed.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: 10423381
• MDR Text Key: 203880676
• Report Number: 2031642-2020-02849
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2015
• 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