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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD 8220 ALARIS SPO2 - MASSIMO; PUMP, INFUSION

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CAREFUSION SD 8220 ALARIS SPO2 - MASSIMO; PUMP, INFUSION Back to Search Results
Model Number 8220 ALARIS SPO2 MODULE
Device Problems Communication or Transmission Problem (2896); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Note: this event was inadvertently reported under incorrect product registration number (manufacturer report number 9616066-2021-00007).This mdr resubmission now reflects the correct product registration number.The customer 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 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
Error code 471.6211.Communication failure in spo2 board.On (b)(6) 2020 07:43:43 (b)(6).Shipping & billing addresses confirmed.There was no patient involvement.
 
Manufacturer Narrative
Addition: updated adverse event codes (h6).
 
Event Description
(b)(4).
 
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Brand Name
8220 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
brett wilko
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key16046236
MDR Text Key308448292
Report Number2016493-2022-1179027
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 Other
Type of Report Initial,Followup
Report Date 06/03/2020
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
Device Operator Other
Device Model Number8220 ALARIS SPO2 MODULE
Device Catalogue Number8220 ALARIS SPO2 MODULE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2020
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/03/2020
Initial Date FDA Received12/26/2022
Supplement Dates Manufacturer Received06/03/2020
Supplement Dates FDA Received03/29/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2012
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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