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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PNEUPAC VENTILATOR; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
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PNEUPAC VENTILATOR; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Device Problem Gas/Air Leak (2946)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Customer facility phone number: (b)(6).
 
Event Description
Information was received indicating that a smiths medical fluid warmer had an internal air leak.There were no reported adverse events.
 
Manufacturer Narrative
Other, other text: h 6 updated no patient involvement.
 
Event Description
Additional information received at smiths medical 13-apr-2021: no patient involvement.
 
Event Description
Additional information received at smiths medical 13-apr-2021: no patient involvement.
 
Manufacturer Narrative
Other, other text: h 6 updated no patient involvement.
 
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Brand Name
PNEUPAC VENTILATOR
Type of Device
VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
MDR Report Key11685947
MDR Text Key246031093
Report Number3012307300-2021-03269
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup,Followup
Report Date 05/18/2021
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 No Information
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/23/2021
Initial Date FDA Received04/19/2021
Supplement Dates Manufacturer Received04/13/2021
04/13/2021
Supplement Dates FDA Received05/17/2021
05/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/04/2021
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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