PORTEX RSP TRACHEAL TUBE HOLDERS H4052

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-08 for PORTEX RSP TRACHEAL TUBE HOLDERS H4052 manufactured by Smiths Medical Internatioal Ltd.

Event Text Entries

[3250157] User facility reported that an infant self-extubated during product use. The report states that the nurse responded to an alarming ventilator and discovered the ett lying in the bed with the holder still attached to the baby's face. The infant was re-intubated and there was no permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5


[10670553] Customer has not yet returned the device to the mfr for device evaluation. When and if the device becomes available and is returned and evaluated the mfr will file a follow-up detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2013-00139
MDR Report Key3059540
Report Source06
Date Received2013-04-08
Date of Report2013-04-05
Date of Event2013-03-03
Date Facility Aware2013-03-03
Report Date2013-04-05
Date Reported to FDA2013-04-05
Date Mfgr Received2013-03-06
Device Manufacturer Date2013-01-01
Date Added to Maude2013-04-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPETE HIRTE
Manufacturer Street1265 GREY FOX RD.
Manufacturer CityST. PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone6516287384
Manufacturer G1SMITHS MEDICAL INTERNATIONAL LTD.
Manufacturer StreetBOUNDARY RD
Manufacturer CityHYTHE, KENT CT216JL
Manufacturer CountryUK
Manufacturer Postal CodeCT21 6JL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORTEX RSP TRACHEAL TUBE HOLDERS
Generic NameJAY - BREATHING TUBE SUPPORT
Product CodeJAY
Date Received2013-04-08
Model NumberNA
Catalog NumberH4052
Lot Number2322827
ID NumberNA
Device Expiration Date2016-01-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age2 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL INTERNATIOAL LTD
Manufacturer AddressHYTHE, KENT


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-04-08

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