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 Circuit Failure (1089); Failure to Sense (1559); Naturally Worn (2988); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection found the device had a cracked frame and the case was chipped and cracked.Technical visual inspection found no anomalies.Device evaluation identified intermittent co2 equipment malfunction.The power board was refurbished with no parts used.The coil was replaced.The device was re-calibrated.The software was set to p.01.46.The case, and front and rear connectors were inspected.All pcb boards were tested.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 co2 malfunction was determined to be the coil of power board becoming worn out due to use.This type of event will continue to be monitored.

Event Description

Reportedly, post repair, the device was displaying a co2 malfunction as soon as the tubing was plugged in.The tubing was changed as well as the monitors with the same result.Additionally, the relay click for the pump can be heard, but it does not run and the co2 malfunction error displays.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: 9324916
• MDR Text Key: 167622301
• Report Number: 3007409280-2019-00099
• 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

• 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: 10/29/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/14/2019
• 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