MAUDE Adverse Event Report: DRAEGER DRAEGER APL VALVE; DRAEGER APL VALVE ANAESTHETIC MACHINE

Device Problems Mechanical Jam (2983); Ventilation Problem in Device Environment (3027)

Patient Problem Hypoventilation (1916)

Event Type  malfunction  

Event Description

Non-beveled draeger apl valves can be jammed open when appear closed leading to inability to ventilate patient, risks hypoxia and death.

• Brand Name: DRAEGER APL VALVE
• Type of Device: DRAEGER APL VALVE ANAESTHETIC MACHINE
• Manufacturer (Section D): DRAEGER
• MDR Report Key: 5584232
• MDR Text Key: 42968021
• Report Number: MW5061736
• Device Sequence Number: 1
• Product Code: BSZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2016

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1