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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC BABYPAC VENTILATOR W/ ALARMS; VENTILATOR, CONTINUOUS, FACILITY USE
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SMITHS MEDICAL ASD, INC. PNEUPAC BABYPAC VENTILATOR W/ ALARMS; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Catalog Number 150003
Device Problems Defective Component (2292); Component Missing (2306); Battery Problem (2885)
Patient Problem Insufficient Information (4580)
Event Date 02/01/2024
Event Type  malfunction  
Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.E3.Initial reporter occupation: operations support specialist.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported that there was physical damage to the battery well and two missing knobs.There was unknown patient involvement and unknown patient harm/adverse event reported.
 
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Brand Name
PNEUPAC BABYPAC VENTILATOR W/ ALARMS
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
Manufacturer Contact
reed covert
6000 nathan lane n
minneapolis, MN 55442
2247062300
MDR Report Key18935757
MDR Text Key338430635
Report Number3012307300-2024-01481
Device Sequence Number1
Product Code CBK
UDI-Device Identifier10610586045578
UDI-Public(01)10610586045578(11)051024
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K970158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number150003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2024
Date Manufacturer Received02/21/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/24/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
LN 150003 SN (B)(6).
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