MAUDE Adverse Event Report: HEWLETT-PACKARD GMBH HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR; MULTIFUNCTION PATIENT MONITOR MODULE

Model Number FMPH7000

Device Problems Defective Component (2292); Naturally Worn (2988); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection found no anomalies.Technical visual inspection found no anomalies.Device evaluation identified that there was an occlusion.The pump assembly was refurbished with no new parts.The circuit boards were inspected.All pcbs were tested.The firmware was set to p.01.32.The device was calibrated.The front and rear connectors as well as the case was inspected for damage.The flow rate, gas calibration test, leak check, power on, and final visual inspection were tested and all passed.The root cause was determined to be the defective pump assembly.This type of event will continue to be monitored.

Event Description

Reportedly, post-repair, the device had a co2 occlusion.The device was on a patient on the time of the event; there was no reported harm.No additional information is available.

• Brand Name: HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR
• Type of Device: MULTIFUNCTION PATIENT MONITOR MODULE
• Manufacturer (Section D): HEWLETT-PACKARD GMBH; herrenberger str. 110-140; boeblingen, 71034 ; GM 71034
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: jenna vargas ; 212 avenida fabricante; san clemente, CA 92672 ; 8004495328
• MDR Report Key: 9356926
• MDR Text Key: 167619992
• Report Number: 3007409280-2019-00103
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FMPH7000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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