MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA VAPOR 2000; ANESTHESIA UNIT VAPORIZERS

Device Problems Restricted Flow rate (1248); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2022

Event Type  Injury  

Event Description

It was reported that the anesthetist could not increase the dosage of sevoflurance beyond 3 vol% due to a blocked control dial at the vaporizer.As per report, the patient woke up before the surgery started.The users administered iv drugs and continued the procedure with a replacement vaporizer; no patient consequences have reportedly occurred.

Manufacturer Narrative

Dräger is waiting for return of the device to start evaluation.Results will be provided in a follow-up report.

Manufacturer Narrative

The owner/operator of the involved vaporizer is the baxter healthcare corporation.Despite repeated reminders were sent, the device was not returned to the manufacturer for evaluation.Without the possibility to evaluate the concerned device, no reliable conclusion in regard to the exact root cause is possible.The device is 14 years old; service status is unknown.It is under responsibility and control of the user to inspect the product prior to each use cycle for mechanical integrity etc.And not to put it into operation when significant deviations are observed.A blocked or free-moving control dial becomes obvious during pre-use check.Furthermore, patient gas monitoring is mandatory for anesthetic procedures whereby potentially resulting dosage deviations would be detected if the device is being put into operation in this state.Post market surveillance data reasonably suggests that the design of the control dial mechanism is adequate for the typical use conditions.H3 other text: device not returned.

Event Description

It was reported that the anesthetist could not increase the dosage of sevoflurance beyond 3 vol% due to a blocked control dial at the vaporizer.As per report, the patient woke up before the surgery started.The users administered iv drugs and continued the procedure with a replacement vaporizer; no patient consequences have reportedly occurred.

Event Description

It was reported that the anesthetist could not increase the dosage of sevoflurance beyond 3 vol% due to a blocked control dial at the vaporizer.As per report, the patient woke up before the surgery started.The users administered iv drugs and continued the procedure with a replacement vaporizer; no patient consequences have reportedly occurred.

Manufacturer Narrative

The device was returned to the manufacturer for evaluation with more than 3 months delay.The device is 14 years old and exhibits a heavy drop damage.The sight glass cover and the sight glass itself were broken, the tank bottom cover was missing and the tank has dent marks.Furthermore, the complained aspect can be confirmed: the knob of the control dial was broken loose while the axis of the delivery unit that shall be rotated by the dial was jammed.It is under responsibility and control of the user to inspect the product prior to each use cycle for mechanical integrity etc.And not to put it into operation when significant deviations are observed.The damages of the vaporizer are multiple and more than obvious and should have prevented from putting the device into operation.Furthermore, a blocked or free-moving control dial becomes obvious during the required pre-use check.It is seen likely that the pre-use check was omitted - otherwise the operator would have recognized that the dial is not operable and should have come to the conclusion that the device can't be used.The reported event must be attributed to a chain of use errors; this is a constellation being beyond the control mechanisms a manufacturer can establish.

• Brand Name: VAPOR 2000
• Type of Device: ANESTHESIA UNIT VAPORIZERS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 14754031
• MDR Text Key: 294607141
• Report Number: 9611500-2022-00152
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• PMA/PMN Number: K971923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2007
• 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