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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: (b)(4) 2019.International udi: (b)(4).Reporter phone number unknown.The philips service engineer (se) inspected the device.The se replaced the central processing unit (cpu) printed circuit board assembly (pcba) and the cpu tray cover.The ventilator passed all testing.

Event Description

It was reported that the ventilator generated a primary alarm failed error code.There was no patient involvement.The event date was not specified; estimate used.

Manufacturer Narrative

Date rec'd by mfr: 26mar2019.Information was received that the cpu (central processing unit) tray cover was replaced due to it being damaged.A cpu pcba (printed circuit board assembly) was returned for analysis.A visual inspection of the returned component was performed, no notable conditions were found.The returned component was installed into a test ventilator for analysis.An investigation was performed and the product analysis technician reported that no fault was found.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: 8348087
• MDR Text Key: 136606666
• Report Number: 2031642-2019-00969
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

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: 02/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2019
• Initial Date FDA Received: 02/18/2019
• Supplement Dates Manufacturer Received: 01/27/2019
• Supplement Dates FDA Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1