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

Model Number V60

Device Problem Defective Device (2588)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 06aug2020.

Event Description

The customer respiratory therapy department reported to the customer biomed department that the device generated a high blower temperature alarm and a co2 rebreathing alarm.The device had been on a patient for several days before the alarms appeared.The respiratory therapist swapped the v60 device with another v60 device.During the transition, the patient experienced a mild oxygen desaturation, but no medical interventions were required, and there was no patient harm.The remote service engineer asked the customer biomed to verify the event log included the check ventilator code for a high blower temperature alarm.The biomed reported that the code was not logged.The remote service engineer asked the customer's biomed to confirm the correct device was delivered to biomed for evaluation.

Manufacturer Narrative

G4: 01sep2020, b4: 02sep2020.After four good faith efforts (email and phone) with no response from the customer biomed, the resolution of the device's problem and disposition is unknown.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: 10377093
• MDR Text Key: 202880904
• Report Number: 2031642-2020-02702
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• 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: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• 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: 1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER