• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION SD 8210 ALARIS SPO2 - MASSIMO; PUMP, INFUSION Back to Search Results
Model Number 8210
Device Problems Break (1069); 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 trackwise files and found relevant to the service repair.A review of the device service history record was performed from the date of manufacture to the date corresponding to this service notification number.The device was returned for service.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 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.Capa reference: (b)(4).The customer stated that there was no patient involvement.
 
Event Description
(b)(4).Physical damage.Customer stated failure speaker test was confirmed due to a broken power board.Also broken rear case at top and bottom.Awaiting for customer's approval with major repair.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
8210 ALARIS SPO2 - MASSIMO
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
suresh gokul selvaraj
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key10738201
MDR Text Key227207675
Report Number2016493-2020-26245
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K010966
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 03/23/2018
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 Received10/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-