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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PNEUPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
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PNEUPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) Back to Search Results
Model Number 120002
Medical Device Problem Codes Failure to Cycle (1142); Wireless Communication Problem (3283)
Health Effect - Clinical Codes No Patient Involvement (2645); No Information (3190)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the frequency is low on a smiths medical ventilator.No adverse patient effects were reported.
 
Event or Problem Description
No patient involvement.
 
Additional Manufacturer Narrative
Other, other text: additional information- no patient involvement.See section b5.Device evaluation- the device was returned for evaluation.The device was given functional and delivery testing and found to meet with specifications.The reported issue could not be confirmed.
 
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Brand Name
PNEUPAC
Common Device Name
VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
MDR Report Key10558199
Report Number3012307300-2020-09584
Device Sequence Number3027887
Product Code BTL
UDI-Device Identifier10610586045479
UDI-Public10610586045479
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K020899
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 10/29/2020
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
Operator of Device Health Professional
Device Model Number120002
Device Catalogue Number120002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 08/31/2020
Supplement Date Received by Manufacturer09/29/2020
Initial Report FDA Received Date09/20/2020
Supplement Report FDA Received Date10/28/2020
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured03/23/2007
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device N
Patient Sequence Number1
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