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

Model Number V60

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 13feb2020.

Event Description

The customer reported high pressure alarms.The service technician confirmed error code indicating pressure regulation high.The service technician confirmed the problem is in the gas module assembly and is waiting for the part to be received.The device was in clinical use at the time the issue was discovered, however, there was no patient or user harm reported.

Manufacturer Narrative

G4: 04mar2020.B4: 09mar2020.The gas delivery system (gds) was replaced to resolve the issue.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: 19may2020.B4: 20may2020.Additional information available in the case indicates that when the ventilator initially annunciated the high pressure alarm, it also showed a message prompting the user to contact technical support and then shutdown.The below patient information was provided: weight: 5 kg, height: 60 cm and sex:: male.The patient had to be moved to another ventilator as a result of this event, however, there was no patient harm.There was no report of additional medical intervention required.Per the product user manual, the ventilator is intended to support pediatric patients weighing 20 kg or greater, to adult patients.Based on the patient's information that was provided, the unit was being used off label.The replaced gas delivery system (gds) was returned for failure analysis.The gds was tested and the customer complaint could not be verified.No fault found.The determination could be made that the device failed to meet specifications.The device was being used for treatment when the reported event occurred.A relationship of the device to the reported problem could not be 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
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 9708872
• MDR Text Key: 183890178
• Report Number: 2031642-2020-00503
• 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: 01/22/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 01/22/2020; 01/22/2020
• Supplement Dates FDA Received: 03/09/2020; 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
• Patient Weight: 5