MAUDE Adverse Event Report: DRAEGERWERK AG & CO. KGAA D-VAPOR; VAPORIZER, ANESTHESIA, NON-HEATED

Model Number M35500

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problems High Blood Pressure/ Hypertension (1908); Palpitations (2467)

Event Date 11/30/2017

Event Type  malfunction  

Event Description

The patient was admitted for removal of an automatic implantable cardioverter-defibrillator (aicd) and cardiac leads in interventional radiology.The patient was intubated and sedated with fentanyl, propofol and rocuronium.Desflurane was being used as gas/inhaled anesthetic agent.Approximately 9 minutes after the patient was intubated she had an increase in bp and heart rate.The desflurane vaporizer gas data was not transmitting to the medical record, and was thought to be a software transmission issue.Clinical engineering was called.A clinical care tech re-seated the vaporizer in the anesthesia machine and it began to function appropriately, transmitting data.The patient was given additional midazolam and propofol in the event she was awake and paralyzed.Fortunately the physicians had used lidocaine to numb the area of the aicd generator area, however the patient did report a significant period of awareness once anesthesia was reversed at the end of the case.She required much post-procedure reassurance.Upon review by clinical engineering it was evident that the cross bar pins on the locking mechanism can easily shear off given the weight of the module, which occurred in this case.If only one of the pins locks the machine may still not be properly seated, but the user would not know using the naked eye since there is no indication the device is slightly askew.In addition, the locking handle has a spring loaded mechanism to keep the lock in place, however it easily breaks and may not ensure the device is properly seated in the anesthesia machine.Finally, there was no alarm indicated that the module was not seated properly, although the gas tracing did not register as anticipated.We think the pin locking mechanism could be better designed to make sure the device is properly seated and locked into the anesthesia machine.We are conducting an inventory of the devices and have found similar defects with other gas vaporizers.Manufacturer response for anesthestic gas vaporizer, desflurane drager d-vapor (per site reporter): no response as yet.

• Brand Name: D-VAPOR
• Type of Device: VAPORIZER, ANESTHESIA, NON-HEATED
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA; beth zis; 6 tech dr; andover MA 01810
• MDR Report Key: 7128007
• MDR Text Key: 95192384
• Report Number: 7128007
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: M35500
• Other Device ID Number: M35500-06; ARWE-0230; BAXTER
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2017
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTHER, PARALYTIC AGENTS, ANESTHESIC AGENTS AND S
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 96