MAUDE Adverse Event Report: TELEFLEX RUSCH DISPOLED; LARYNGOSCOPE HANDLE

Lot Number 1321005

Device Problem Defective Component (2292)

Patient Problem No Information (3190)

Event Date 01/23/2015

Event Type  malfunction  

Event Description

Rusch disposable laryngoscope handle defective when taken from packaging during "code blue." the bottom holding the batteries popped off without notice sending the batteries and spring across the room.Event abated after use stopped.Reason for use: intubation.

• Brand Name: RUSCH DISPOLED
• Type of Device: LARYNGOSCOPE HANDLE
• Manufacturer (Section D): TELEFLEX
• MDR Report Key: 4484049
• MDR Text Key: 5568005
• Report Number: MW5040571
• Device Sequence Number: 1
• Product Code: CCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/29/2015

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: Other
• Device Expiration Date: 12/10/2016
• Device Lot Number: 1321005
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2015
• Patient Sequence Number: 1
• Patient Age: 34 YR