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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD 8300 ALARIS ETCO2 MODULE; PUMP, INFUSION

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CAREFUSION SD 8300 ALARIS ETCO2 MODULE; PUMP, INFUSION Back to Search Results
Model Number 8300
Device Problem Charging Problem (2892)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The customer¿s reported problem was confirmed.A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was not returned for servicing which not correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode the customer stated that there was no patient involvement.
 
Event Description
Case #: 00810066 case subject: npi 8300 no power account name: mercy san juan hospital account #: 1470202 asset name: 8300 etco2 module, v8 asset location: contact: mark bautista contact email: mark.Bautista@dignityhealth.Org contact phone: 9162040494 contact mobile: patient or user involvement: no patient or user harm: no case description: customer called reporting no power on their 8300 (sn: (b)(4)).Failure device type: alaris system instrument failure problem type: 8300 failure mode: troubleshooting/ error codes case resolution: customer stated they already replaced the power supply board as directed by technical support.At this point i recommended installing the old power supply board, and send in for repair.Customer will call back with po.Ended call.
 
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Brand Name
8300 ALARIS ETCO2 MODULE
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
madhavan ezhumalai
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key11045072
MDR Text Key232837654
Report Number2016493-2020-75299
Device Sequence Number1
Product Code CCK
UDI-Device Identifier10885403830013
UDI-Public10885403830013
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031741
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/22/2019
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 Other
Device Model Number8300
Device Catalogue Number8300
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2015
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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