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MAUDE Adverse Event Report: NULL; TRACHEOSTOMY TUBE
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NULL; TRACHEOSTOMY TUBE
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Model Number
100/150/065
Device Problem
Inflation Problem (1310)
Patient Problem
Insufficient Information (4580)
Event Date
10/01/2021
Event Type
malfunction
Event Description
It was reported that it was reported the cuff didn't remain inflated on a smiths medical trach tube.This incident occurred after use on the patient in the recovery room at the time of extubation.No health consequence for the patient.
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Type of Device
TRACHEOSTOMY TUBE
Manufacturer
(Section G)
NULL
MDR Report Key
12808349
MDR Text Key
280771649
Report Number
3012307300-2021-11224
Device Sequence Number
1
Product Code
BTO
Combination Product (y/n)
N
Reporter Country Code
FR
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Manufacturer
Reporter Occupation
Other Health Care Professional
Type of Report
Initial
Report Date
11/14/2021
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 Model Number
100/150/065
Device Catalogue Number
100/150/065
Was Device Available for Evaluation?
No
Is the Reporter a Health Professional?
Yes
Was the Report Sent to FDA?
No
Initial Date Manufacturer Received
11/02/2021
Initial Date FDA Received
11/14/2021
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
Patient Sequence Number
1
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