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

Model Number FMPH7006

Device Problems Circuit Failure (1089); Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2019

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 a c02 malfunction and a defective power board.The power board was refurbished with no new parts used.The firmware was set to p.01.46.All pcbs were tested.The circuit boards were inspected.The front and rear connectors were inspected.The case was checked for damage.The unit was calibrated.The flow rate, gas calibration, leak check, and power on tests were performed and passed.It was determined that this was not related to the previous repair.The root cause for the reported issue was determined to be a defective power board.This type of event will continue to be monitored.

Event Description

Reportedly, post repair, the device has a c02 malfunction.There was no report of patient involvement.No additional information is 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: 9248008
• MDR Text Key: 177998678
• Report Number: 3007409280-2019-00066
• 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: FMPH7006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 10/28/2019
• 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