MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH MRI COND FIBER OPTIC LARYN KIT; MRI LARYNGOSCOPE KIT

Catalog Number 005852300

Device Problems Inadequate Lighting (2957); Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2014

Event Type  malfunction  

Event Description

The customer alleges that the light bundle will not light on the mac 2 blade.Intubation was accomplished with a standard laryngoscope set.No patient injury reported.

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that the light bundle will not light on the mac 2 blade.Intubation was accomplished with a standard laryngoscope set.No patient injury reported.

• Brand Name: RUSCH MRI COND FIBER OPTIC LARYN KIT
• Type of Device: MRI LARYNGOSCOPE KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck drive; research triangle park NC 27709
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4884497
• MDR Text Key: 6024386
• Report Number: 1044475-2015-00216
• Device Sequence Number: 1
• Product Code: OGH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 005852300
• Device Lot Number: 132601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1