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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC PARAPAC VENTILATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC PARAPAC VENTILATOR; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) Back to Search Results
Model Number 200
Device Problem No Flow (2991)
Patient Problem Cardiac Arrest (1762)
Event Date 12/01/2019
Event Type  Injury  
Event Description
Information was received indicating that during a magnetic resonance imaging (mri) of a patient on a smiths medical pneupac parapac ventilator the customer had attached the patient valve in an opposite direction by mistake; obstructing air flow.The patient went into cardiac arrest due to obstructed airflow.The patient was resuscitated, and the patient's heartbeat was recovered.An mri was later performed revealing minor hypoxic encephalopathy.It was reported that the patient had been undergoing immunotherapy for anti-n-methyl-d-aspartate (anti-nmda) for encephalitis and is receiving treatment for brain injury with no further reported adverse effects.
 
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Brand Name
PNEUPAC PARAPAC VENTILATOR
Type of Device
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
Manufacturer (Section D)
SMITHS MEDICAL INTERNATIONAL, LTD.
bramingham business park, enterprise way
luton, bedforshire LU3 4 BU
UK  LU3 4BU
MDR Report Key10006346
MDR Text Key189222643
Report Number3012307300-2020-03436
Device Sequence Number1
Product Code BTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 04/28/2020
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 No Information
Device Model Number200
Device Catalogue NumberP200DNJ
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/08/2020
Initial Date FDA Received04/28/2020
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
Type of Device Usage Unknown
Patient Sequence Number1
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