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

Model Number V60

Device Problems Increase in Pressure (1491); Self-Activation or Keying (1557)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 03feb2021.

Event Description

It was reported to philips that when a patient was on the unit with the following settings: s/t mode epap:7,ipap:7, the pip was applied with the pressure 14 to 15.The customer stated the pressure also increased on its own with cpap mode.There was also an abnormal sound in the blower observed.The device was in use at the time of the event.Once it was found that the displayed pressure value was faulty, the patient was swapped to another v60 immediately.There was no report of patient harm and no delay to patient care or treatment reported.The unit was collected and testing was run in the sales office, but the reported phenomenon didn't occur.A philips service technician evaluated the ventilator and an operational check was performed, but the reported phenomenon was unable to be confirmed.A flow/flow rate accuracy test was also performed.The device successfully passed all required testing.No other repair actions were taken and the device was returned to the sales office.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 11276172
• MDR Text Key: 231127868
• Report Number: 2031642-2021-00421
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• 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
• Report Date: 01/07/2021

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
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2019
• 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