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

Model Number FGPH1026B

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned.Device evaluation identified that the device came in with the micron filter disconnected and the pump was bad.The pump was replaced.The fan, fan filter, flow rate, gas calibration, leak, power on, pressure sensor, and final visual inspection were checked/tested and all passed.The root cause was determined to be the defective pump.This type of event will continue to be monitored.

Event Description

Reportedly, post repair, the device's o2 zero failed and agm zero failed.There was no report of 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: 9406819
• MDR Text Key: 178000997
• Report Number: 3007409280-2019-00121
• 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: 11/08/2019

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: 11/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/03/2019
• 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