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

Model Number V60

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Reported: 17feb2021.

Event Description

It was reported to philips that the device was displaying low leak co2 diagnostic code.The device was not in clinical use at the time of the event.There was no report of patient or user harm.The device was evaluated by the customer (biomed) with assistance from a philips remote service engineer (rse).The biomed has reportedly completed pneumatics performance verification testing and is reporting all tests are passing and that the v60 exhalation port is not occluded.The rse informed the customer the recommended repair is to replace the v60 gds.The customer requested to close the service order and stated he would return a call if there were any additional questions.

Manufacturer Narrative

G4:23mar2021 b4:(b)(6) 2021 multiple good faith efforts were made to obtain information regarding device evaluation, repair, and operational status with no response from the reporter and therefore cannot be determined.It is unknown if any parts or repair has been conducted.The customer's alleged malfunction could not be confirmed.If new information is received, a supplemental report will be submitted.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: 11339798
• MDR Text Key: 233748676
• Report Number: 2031642-2021-00631
• 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: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• 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
• Date Manufacturer Received: 01/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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