MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DISPOLED DIS FO LARYNGOSCOPE HANDLE

Catalog Number 77700

Device Problem Battery Problem (2885)

Patient Problems Hypoxia (1918); No Consequences Or Impact To Patient (2199)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

The customer alleges that the dispoled handle was defective.This caused a delay in intubation and caused further hypoxemia.No patient injury reported.

Manufacturer Narrative

Qn#(b)(4).A conclusion code could not be chosen.The complaint was confirmed, but the root cause is unknown.Upon receipt of the complaint sample a visual inspection/review was performed.It was immediately noted that the three (3) aaa batteries were very much corroded.There was also heavy corrosion on the battery cartridge metal/plated components.The complaint has been confirmed.With the current complaint information provided a definitive root cause cannot be established.No corrective/preventative actions will be assigned.The complaint has been confirmed.With the current complaint information provided a definitive root cause cannot be established.No corrective/preventative actions will be assigned.The complaint has been confirmed.With the current complaint information provided a definitive root cause cannot be established.

• Brand Name: RUSCH DISPOLED DIS FO LARYNGOSCOPE HANDLE
• Type of Device: LARYNGOSCOPE HANDLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck dr.; research triangle park NC 27709
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd.; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4834405
• MDR Text Key: 5904296
• Report Number: 1044475-2015-00177
• 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: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2015

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: Health Professional
• Device Catalogue Number: 77700
• Device Lot Number: 13Z2405
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1