PNEUPAC? SINGLE USE PATIENT CIRCUIT KITS 100/905/320

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-04-10 for PNEUPAC? SINGLE USE PATIENT CIRCUIT KITS 100/905/320 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[72298625] Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation. Patient's age was not provided; however. It was reported that the patient was a "baby" it was reported that the event occurred in (b)(6) 2017; however, the exact date was not provided.
Patient Sequence No: 1, Text Type: N, H10


[72298626] It was reported that immediately upon patient use of the babypac ventilator it was observed that the disposable pneupac? Single use patient circuit had two splits down the side of the plastic. It was further reported that the tubing broke apart at the "22f connector ventilator end". The observed issue resulted in the patient not being ventilated properly for a short period of time. According to the report, medical intervention was needed and a neopuff? Was used to deliver the required pressure to the patient. The reported incident was observed immediately upon patient use. No permanent adverse effects to patient reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2017-00817
MDR Report Key6477697
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-04-10
Date of Report2017-04-10
Date Mfgr Received2017-03-17
Device Manufacturer Date2016-09-02
Date Added to Maude2017-04-10
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 ContactLISA PERZ
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone7633833074
Manufacturer G1SMITHS MEDICAL INTERNATIONAL NIJMEGEN
Manufacturer StreetBIJSTERHUIZEN 22 - 08
Manufacturer CityWIJCHEN, LD 6604
Manufacturer CountryNL
Manufacturer Postal Code6604
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePNEUPAC? SINGLE USE PATIENT CIRCUIT KITS
Generic NameATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
Product CodeBYE
Date Received2017-04-10
Catalog Number100/905/320
Lot Number160704
Device Expiration Date2019-07-04
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-04-10

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