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 Improper Flow or Infusion (2954); Naturally Worn (2988); No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection identified a cracked case.Technical visual inspection did not identify any anomalies.Device evaluation identified a co2 equipment malfunction.This confirmed the reported event of an equipment malfunction.The power board was refurbished with no new parts, the firmware was set to p.01.46, the device was calibrated, the front and rear connectors were inspected, the case was checked for damage, and all pcb boards were inspected.The device tested to oem specifications.The root cause was determined to be the aging coil of the power board; however, this was not related to the previous repair.This type of event will continue to be monitored.

Event Description

Reportedly, post repair, the device displayed error code - equipment malfunction.There was no patient involvement.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: 9153739
• MDR Text Key: 167648392
• Report Number: 3007409280-2019-00029
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• 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: 09/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2019
• 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