MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE G5 AGM; GAS MONITOR

Model Number M1019A

Device Problem Defective Component (2292)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 04/04/2018

Event Type  Injury  

Manufacturer Narrative

The customer provided to a philips quality and regulatory officer that the patient received general anesthesia for a cesarean section.The anesthesiologist confirmed the patient was over anaesthetized, which had a risk of decreasing uterine contractions and during the operation they were struggling with uterine contractions and uterine hemorrhaging.The anesthesiologist felt the need to administer midazolam as an adjunct, which caused post-op drowsiness.The anesthesiologist confirmed there was no severe health impact to the patient and the patient was doing well following the procedure.The anesthesiologist also provided that when the device was not producing any numeric values, there were no errors displayed.The anesthesiologist changed the gas measuring line and there was no change in the monitoring values and they continued to display a question mark.The patient was attended to at all times during the anesthetic procedure.Monitoring returned when the anesthesiologist turned off the gas monitoring device and restarted it.There is no evidence of user related issues to the reported failure.There was no onsite engineer evaluation of the device.The customers internally trained engineer found no fault with the gas module device.The engineer thoroughly checked the gas module and confirmed the flows, pressure, ambient measurement and calibrations were all working.The engineer reported these findings to the customer.Although philips cannot rule out a malfunction, there is no data to support that a conclusion is available, therefore no conclusion can be determined.The customers internally trained engineer found no fault with the gas module device.The engineer thoroughly checked the gas module and confirmed the flows, pressure, ambient measurement and calibrations were all working.The surgical procedure was completed successfully using alternate ways of monitoring.This failure mode is obvious to clinicians, and clinicians can use other monitoring methods or troubleshoot as needed.The device is currently not in use and has been sent to philips for further evaluation.No further investigation is warranted at this time.(b)(6).

Event Description

The customer reported that following intubation during a general anesthesia (ga) cesarean section, the gas module failed.The gas module failed to adequately monitor the patient, which resulted in the patient requiring additional medications to ensure that the anesthesia was effective, which affected the labor during the cesarean section.

• Brand Name: INTELLIVUE G5 AGM
• Type of Device: GAS MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8992242
• MDR Text Key: 161170342
• Report Number: 9610816-2019-00212
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K060541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1019A
• Device Lot Number: .
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2011
• 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
• Patient Outcome(s): Required Intervention