MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR

Model Number V1000

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 08jun2020.

Event Description

The customer reported the unit went vent inoperable at turned on.The customer reported that the unit was not in use on patient.The customer contacted product support and requested for service repair.Product support advised customer to replaced power supply and the issue continued, the customer swapped in a central processing unit (cpu) board and the issue continued.The customer swapped in a main harness.The customer found that the unit would start in diagnostics with the screen blank.Tried a video graphics array (vga) card and the issue remained the same.Continued troubleshooting and found that the customer did not have the shroud with the direct current (dc) to dc converter connected.The customer reconnected the dc to dc converter and noted that the unit would now operate correctly.The customer replaced the main cable harness to address the reported issue.

• Brand Name: ESPRIT VENTILATOR
• Type of Device: VENTILATOR
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; carlsbad CA
• Manufacturer Contact: bill cole ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 10131195
• MDR Text Key: 194793739
• Report Number: 2031642-2020-02004
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2003
• 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