MAUDE Adverse Event Report: HEWLETT-PACKARD GMBH PHILIPS M3015A ETCO2 MODULE OPTION C06; DETECTOR AND ALARM, ARRHYTHMIA

Model Number FMPH7006

Device Problems Mechanical Problem (1384); Improper Flow or Infusion (2954); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

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 found that there was a co2 power board equipment malfunction.The power board was refurbished with no new parts.The coil was replaced.The connectors were inspected.The case was inspected.Firmware was set to p.01.46 and the device was calibrated.The flow rate check, gas calibration and leak check were all tested and passed.The root cause for the confirmed reported event was determined to the coil of the co2 power board malfunctioning due to wear and tear.This type of event will continue to be monitored.

Event Description

This device was sent in without a reported issue.It is unknown if there was patient involvement.There was no patient harm reported.No additional information is available.Device evaluation identified a co2 equipment malfunction.

• Brand Name: PHILIPS M3015A ETCO2 MODULE OPTION C06
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• 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: 9311983
• MDR Text Key: 177837900
• Report Number: 3007409280-2019-00094
• 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: 10/18/2019

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: FMPH7006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/12/2019
• 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