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); Improper Flow or Infusion (2954); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned.Device evaluation identified that the top case damaged and the bottom case locking cam was broken.The error log showed solenoid 1 and 2 failure, and the lamp was only reading co2 up to 4.7.The unit was ran for 28 hours confirming the intermittent connection and failure to zero out.The pump outlet filter, lamp, locking cam, top case, and rs232 cable were all replaced.The unit was tested for 24 hours showing that the solenoid issue 1 and 2, connection, and zero issues resolved.The root cause was determined to be the micron filter and rs232 cable.As the pump is ran shavings from pump are caught purposely by micron filter causing it to fill up over time.The rs232 cable showed normal wear and tear due to long run hours.This type of event will continue to be monitored.

Event Description

Reportedly, post repair, the device would not zero and displayed 02 assembly failure.It is unknown if there was patient involvement.There was no report of patient harm.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: 9399544
• MDR Text Key: 177824601
• Report Number: 3007409280-2019-00120
• 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: 11/05/2019

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: 11/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/02/2019
• 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