MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR

Catalog Number MEDICAL UNKNOWN

Device Problem Inflation Problem (1310)

Patient Problem No Patient Involvement (2645)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported "unable to insert any air into cuff" during demonstration on a mannequin after initially inflating cuff.The device was inserted into the mannequin and the cuff pilot marker was in the red zone.The device was removed and another attempt made to insert air.The cuff would not inflate or deflate and the cuff pilot marker would not come back down.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Customer reported "unable to insert any air into cuff" during demonstration on a mannequin after initially inflating cuff.The device was inserted into the manniquin and the cuff pilot marker was in the red zone.The device was removed and another attempt made to insert air.The cuff would not inflate or delfate and the cuff pilot marker would not come back down.

• Brand Name: LMA PROTECTOR
• Type of Device: LMA PROTECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9174805
• MDR Text Key: 182597418
• Report Number: 9681900-2019-00045
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

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: No Information
• Device Catalogue Number: MEDICAL UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.