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

Model Number V60

Device Problems Output Problem (3005); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2018.Date of report:(b)(6) 2018.Philip's field service engineer (fse) evaluated the device and could not duplicate the reported malfunction however, the error code was verified in the event log.To address the issue, the fse replaced the blower assembly per the service manual.The ventilator passed all testing and operated within the manufacturing specifications.

Event Description

The customer reported that during clinical use, the ventilator generated an error relevant to high blower temperature.The ventilator was in clinical use at the time of the event.No patient harm was reported.The event date was not specified; estimate used.

Manufacturer Narrative

Date of report: 16jan2019.Date rec'd by mfr: 14jan2019.The blower assembly was received at philips for evaluation.A visual inspection of the blower assembly outer surface revealed no evidence of damage or contamination.The blower assembly passed all testing.A high blower temperature alarm (1122 error code) could not be duplicated.There were no faults found with the blower assembly.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: 8037924
• MDR Text Key: 127896854
• Report Number: 2031642-2018-02376
• Device Sequence Number: 0
• Product Code: MNT
• 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: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• 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: 11/28/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT CIRCUIT, MASK, HUMIDIFIER: UNKNOWN