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)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

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 the pump assembly had a malfunction confirming the reported issue.The motor was replaced and the pump assembly was refurbished with no new parts.The software was set to p.01.30.The device was calibrated.The front and rear connectors were inspected.All pcb boards were checked.The firmware revision, flow rate, gas calibration, leak check, mounting integrity, power on test, and final vision inspection tests were performed and passed as well.The root cause for the reported event was determined to be the aging motor of pump assembly causing the co2 occlusion.This type of event will continue to be monitored.

Event Description

Reportedly, post repair, the device had a c02 occlusion.It is unknown if there was patient involvement.There was no report of patient harm.No additional information available.

• 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: 9290894
• MDR Text Key: 177823479
• Report Number: 3007409280-2019-00074
• 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: 10/16/2019

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: 10/08/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/07/2019
• 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