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

Model Number V60

Device Problem Failure to Zero (1683)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 11nov2021.

Event Description

It was reported to philips that the device has error 110b shows message unable to zero proximal sensor.The device was not in use at the time of the event.This issue occurred during testing, prior to putting in clinical use.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer mentioned they received this device from the healthcare repair facility (hrf) in november and now when customer tested prior to putting in clinical use, it was noticed the device shows error unable to zero proximal sensor.The rse advised the customer this fault is not related to previous case and solenoid valves or data acquisition board could be deflective.The customer will be sending to hrf and is aware that a quote will be sent for this job.

Manufacturer Narrative

G4:02feb2021.B4:04feb2021.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer mentioned they received this device from the healthcare repair facility (hrf) in november, and now when the customer tested prior to putting it in clinical use, it was noticed the device shows error unable to zero proximal sensor.The rse advised the customer this fault is not related to the previous case, and solenoid valves or the data acquisition board could be defective.The customer will be sending it to hrf and is aware that a quote will be sent for this job.The device was returned to the hrf for repair, and it was found that solenoid 4 was bent and misaligned, so the device was unable to zero the proximal sensor.The hrf repair technician replaced the solenoid and solenoid seals, and functional and safety tests passed successfully.The device has been confirmed to be working under specification and was returned to the customer.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: 11148186
• MDR Text Key: 227579068
• Report Number: 2031642-2021-00110
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009851
• UDI-Public: (01)00884838009851
• 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
• Report Date: 12/16/2020

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
• Device Catalogue Number: 1053614
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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