MAUDE Adverse Event Report: UNKNOWN SMH INTUBATION HANDLE EMCASTRO - STRRD-STD; LARYNGOSCOPE HANDLE

Device Problems Failure to Power Up (1476); Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 11/23/2015

Event Type  malfunction  

Event Description

When setting up for cardiac arrest patient intubation, handle did not work.The light did not turn on.Switched blades and light still did not work.Opened second tray to get another handle.Device had been serviced just over one month before this event.

• Brand Name: SMH INTUBATION HANDLE EMCASTRO - STRRD-STD
• Type of Device: LARYNGOSCOPE HANDLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5253934
• MDR Text Key: 32268140
• Report Number: 5253934
• Device Sequence Number: 1
• Product Code: CCW
• 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: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Other Device ID Number: O.R. - 000
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/24/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR