PNEUPAC? PARAPAC? VENTILATOR 120003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-31 for PNEUPAC? PARAPAC? VENTILATOR 120003 manufactured by Smiths Medical Asd; Inc..

Event Text Entries

[185923991] Information was received indicating that the battery to a smiths medical pneupac? Parapac? Ventilator was broken off on the side. It was reported to be not giving low pressure alarms. The unit was also due for preventative maintenance and calibration. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02643
MDR Report Key9908320
Report SourceUSER FACILITY
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-02
Device Manufacturer Date2012-12-20
Date Added to Maude2020-03-31
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 ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE N
Manufacturer CityMINNEAPOLIS,, MN
Manufacturer CountryUS
Manufacturer Phone3833310
Manufacturer G1SMITHS MEDICAL INTERNATIONAL LTD
Manufacturer StreetBRAMINGHAM BUSINESS PARK ENTERPRISE WAY
Manufacturer CityLUTON, BEDS LU3 4BU
Manufacturer CountryUK
Manufacturer Postal CodeLU3 4BU
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePNEUPAC? PARAPAC? VENTILATOR
Generic NameVENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
Product CodeBTL
Date Received2020-03-31
Returned To Mfg2020-03-11
Model Number120003
Catalog Number120003
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD; INC.
Manufacturer Address6000 NATHAN LANE N MINNEAPOLIS,, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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