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

Model Number V60

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Event date: (b)(6) 2018.Date of report: 31dec2018.International udi # (b)(4).A follow-up report will be submitted once the investigation has been completed.

Event Description

During periodic maintenance, the manufacturer¿s international service technician reported the unit failed the pressure accuracy test.There was no patient involvement.The event date was not specified; estimate used.

Manufacturer Narrative

Report date: 25jan2019, date received by mfr: 23jan2019.The manufacturer¿s international service technician replaced the data acquisition (da) printed circuit board assembly to address the reported problem.The unit was checked overall, run in tested, cleaned and functionally tested and no abnormality was confirmed.

Manufacturer Narrative

Date rec'd by mfr: 17apr2019.The data acquisition printed circuit board assembly (da pcba) was returned to the manufacturer's failure investigation lab for evaluation.Visual inspection of the da pcba revealed no evidence of damage or contamination.The da pcba was installed into the fi test ventilator to verify & test its functional integrity.From testing, it was determined that the test ventilator utilized with the returned da pcba passed all testing, and no errors were generated.The reported complaint of a ventilator with a failed pressure accuracy test was not duplicated, no fault was found on the returned da pcba.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: 8207288
• MDR Text Key: 131767295
• Report Number: 2031642-2018-03121
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• 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: 02/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1