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

Model Number FGPH1026B

Device Problem Complete Loss of Power (4015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Device sent in due to the device shutting down in the middle of a procedure.Incoming visual inspection found no anomalies.Device evaluation found no problem.The device was calibrated, the case and front/rear connectors were inspected.The circuit boards were inspected.The reported event was unable to be duplicated and there was no problem found; therefore, a root cause cannot be determined.This type of event will continue to be monitored.It should be noted that this is being filed based on retrospective review.

Event Description

Reportedly, post repair, the device failed during a procedure as it shut off.There was no report of patient harm or intervention.No additional information is available.

• 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: 9684663
• MDR Text Key: 178965787
• Report Number: 3007409280-2020-00040
• 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: 07/23/2018

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: 08/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 02/07/2020
• 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