MAUDE Adverse Event Report: DRAGER MEDICAL INC. DRAGER APOLLO ANESTHESIA WORKSTATION; APL VALVE ON WORKSTATION

Device Problems Entrapment of Device (1212); Decrease in Pressure (1490); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2014

Event Type  No Answer Provided  

Event Description

Stent was having c-section under general anesthesia.At anesthesia workstation machine, the etco2 tubing was caught under the apl valve which was not obvious visually, nor was it obvious when closing the apl valve.The crna was unable to ventilate a pt because she could not hold pressure (the bag deflated even with the apl valve completely closed).The crna was unable to give positive pressure ventilation with valve completely closed.Event occurred with induction without any harm to the pt.The mfr was made aware of the problem by the hospital rep immediately after the incident.It was revealed from the mfr that the design issue with the etco2 getting caught under the apl valve was first recognized by the mfr in august 2008 and there is literature available about it.The apl valve has been redesigned on the newer machines and the problem corrected.The mfr rep reported the fix for the problem with older models like the hospital's (2006 machines) is to secure the etco2 tubing and routing it off the side of the machine away from the apl valve where it does not interfere at all with the circuit or pt care.

• Brand Name: DRAGER APOLLO ANESTHESIA WORKSTATION
• Type of Device: APL VALVE ON WORKSTATION
• Manufacturer (Section D): DRAGER MEDICAL INC.; telford 18969
• MDR Report Key: 4135241
• MDR Text Key: 20012142
• Report Number: MW5038396
• Device Sequence Number: 1
• Product Code: BSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 92