MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH PHILIPS M1026B ANESTHETIC GAS MODULE

Model Number FGPH1026B

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection did not identify any anomalies.Technical visual inspection did not identify any anomalies.Technical visual inspection corner damage on the top case.Device evaluation found that the o2 module had a communication error and the o2 reading was too high.Additionally, the pump was failing the calibration flow check.The pump was replaced.The o2 module was replaced, and the o2 communicating and reading was set at the correct level.The device was calibrated and the tested to oem specification.The fan, fan filter, flow rate, gas calibration and span test, leak check, power on test, and pressure sensor were all checked all passed.The root cause was determined to be that the pump was aged most likely from long run hours.This was related to the previous repair.This type of event will continue to be monitored.

Event Description

Reportedly, post repair, the o2 analyzing channel failed.There was no patient harm reported.No additional information is required.

• Brand Name: PHILIPS M1026B ANESTHETIC GAS MODULE
• Type of Device: ANESTHETIC GAS MODULE
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH; hewlett-packard-str.-2; 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: 9212555
• MDR Text Key: 167651135
• Report Number: 3007409280-2019-00046
• Device Sequence Number: 1
• Product Code: CBQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040917
• 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: 09/27/2019

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: FGPH1026B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/20/2019
• 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