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

Model Number FGPH1026B

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Date 10/17/2019

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 the mirrors had broken off inside of the dir, the pump was grinding metal on metal and solenoids #1 and #2 of the pump had failed.Due to the damage of the device it was not repaired; however, it was exchanged.The root cause for the confirmed reported malfunction was determined to be the dir pump and pneumatic assembly due to long run hours and normal wear and tear.This type of event will continue to be monitored.

Event Description

Reportedly, post repair, the device was getting a 02 assembly failure.There was no patient involvement.No additional information is available.

• Brand Name: PHILIPS M1026B ANESTHETIC GAS ANALYZER
• 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: 9307433
• MDR Text Key: 167622476
• Report Number: 3007409280-2019-00089
• 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: 10/17/2019

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: 10/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/11/2019
• 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