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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 3 (150030)
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TELEFLEX MEDICAL LMA PROSEAL, REU, SIZE 3 (150030) Back to Search Results
Catalog Number 15130
Device Problem Deflation Problem (1149)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 07/06/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is in progress.
 
Event Description
Customer complaint alleges the nurse found the cuff could not be deflated.Alleged malfunction reported as detected prior to use.There was no report of patient harm.There was no report of patient involvement.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was noticed that the airway tube was lightly yellowish due to multiple uses.There was no physical damage observed from the outer profile of the device.It was also found that the red plug opening was blocked by the check valve.The device could be inflated and deflated normally with the check valve.The cuff could not be deflated with the red plug opened.The failure was verified.The probable root cause is that excessive force was applied to the valve inside the blue inflation balloon when inflating and deflating the device over a prolonged period of time.The valve sunk further into the tubing , which resulted in the red plug opening being blocked by the valve.The device is still functional and can be inflated and deflated using the check valve.
 
Event Description
Customer complaint alleges the nurse found the cuff could not be deflated.Alleged malfunction reported as detected prior to use.There was no report of patient harm.There was no report of patient involvement.
 
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Brand Name
LMA PROSEAL, REU, SIZE 3 (150030)
Type of Device
LMA PROSEAL
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
Manufacturer (Section G)
THE LARYNGEAL MASK COMPANY
6 battery road #07-02
singapore 04990 9
SN   049909
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6773190
MDR Text Key82057670
Report Number9681900-2017-00034
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/20/2017
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 Number15130
Device Lot Number8WRABRHU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/20/2017
Initial Date FDA Received08/08/2017
Supplement Dates Manufacturer Received09/13/2017
Supplement Dates FDA Received09/15/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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