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

Model Number M3015A

Device Problems Failure to Sense (1559); Deformation Due to Compressive Stress (2889); Naturally Worn (2988); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection found light scratches on the casing.Technical visual inspection found no anomalies.Device evaluation identified that the device had a co2 malfunction and an ecg out malfunction.The lamp and msl connector were replaced.The device was re-calibrated and tested to oem specifications.The software was set to p.01.46.The case, and front and rear connectors were inspected.The firmware revision, flow rate, gas calibration, and leak check, were all tested and passed.The root cause for the co2 equipment malfunction was the bad lamp.The root cause for the ecg out malfunction was the msl bad msl connector.This type of event will continue to be monitored.This device was previously reported under mfr# 3007409280-2019-00029.

Event Description

Reportedly, post repair, the device was not working properly.The co2 readings were off and the device was running quietly.There was no report of patient 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: 9324693
• MDR Text Key: 167623613
• Report Number: 3007409280-2019-00098
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2019
• 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