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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD 8210 ALARIS SPO2 - NELLCOR; PUMP, INFUSION

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CAREFUSION SD 8210 ALARIS SPO2 - NELLCOR; PUMP, INFUSION Back to Search Results
Model Number 8210
Device Problems Break (1069); Circuit Failure (1089); Crack (1135); Charging Problem (2892)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
This reported event and subsequent repairs were investigated through the service repair process.Failure data and parts-used information were reviewed for the sap and track wise files and found relevant to the service repair.A review of the source device service history record was performed from the date of manufacture to the date corresponding to this service notification number.The database showed no quality notifications were opened for the device.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 returned for servicing which 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
(b)(4).
 
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Brand Name
8210 ALARIS SPO2 - NELLCOR
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
sivaraman subramanian
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key10967513
MDR Text Key230020922
Report Number2016493-2020-60404
Device Sequence Number1
Product Code DQA
UDI-Device Identifier10885403821011
UDI-Public10885403821011
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022677
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 02/25/2019
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 Number8210
Device Catalogue Number8210
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2014
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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