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

Model Number V60

Device Problems Break (1069); Loose or Intermittent Connection (1371); Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 06dec2019.

Event Description

The customer reported unit not operating.The service technician reviewed the diagnostic report and found error codes consistent with blower stalled, backup alarm failed, auxiliary alarm supply failed, 35 v (voltage) supply failed and confirmed the unit was not secure on the stand and the unit was missing a filter cover.The device was not in clinical use at the time the issue was discovered, therefore, there was no patient or user harm reported.The service technician replaced the power management board to resolve the problem.The service technician also replaced the cpu (central processing unit) tray cover, bottom foot, and thumbwheel to secure the unit to stand.The technician also installed a missing filter cover.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 9433055
• MDR Text Key: 194007063
• Report Number: 2031642-2019-10766
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2019

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1