MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH PHILIPS ANESTHESIA GAS MONITOR; ANESTHETIC GAS MODULE

Model Number M1026B

Device Problems Pumping Problem (3016); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection identified case damage and that there was no water trap.Technical visual inspection identified no anomalies.Device evaluation found that the pump was very weak.This was not related to the previous repair as this is part was not repaired at that time.The pump was replaced and the device tested to oem specifications.A definitive root cause for the device turning off could not be determined; however, it is likely that it was related to the bad pump.This type of event will continue to be monitored.

Event Description

Reportedly, post repair, the device turns off during use.There was no patient harm reported.No additional information is available.

• Brand Name: PHILIPS ANESTHESIA GAS MONITOR
• 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: 9106792
• MDR Text Key: 177832802
• Report Number: 3007409280-2019-00020
• 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: 08/27/2019

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: M1026B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/23/2019
• 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