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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD LIFECARE PCA 3 V5.06; 80MEA
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HOSPIRA COSTA RICA LTD LIFECARE PCA 3 V5.06; 80MEA Back to Search Results
Catalog Number 20709
Device Problem Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 07/21/2014
Event Type  malfunction  
Event Description
The customer contact reported that while configuring the drug library, the device started to smoke.There were no reports of adverse patient events or delays in critical therapy while the device was in clinical use.No additional information was provided.
 
Manufacturer Narrative
The device was received.Investigation is not complete.This report represents all the information known by the reporter upon query by hospira personnel.
 
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Brand Name
LIFECARE PCA 3 V5.06
Type of Device
80MEA
Manufacturer (Section D)
HOSPIRA COSTA RICA LTD
zona franca global
la aurora heredia
CS 
Manufacturer (Section G)
HOSPIRA COSTA RICA LTD.
zona franca global
la aurora heredia
CS  
Manufacturer Contact
juergen schmider, md, vp
275 n. field drive
bldg no h2-1east dept no 097u
lake forest, IL 60045
2242125740
MDR Report Key4060301
MDR Text Key4908534
Report Number9615050-2014-04726
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042800
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 07/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number20709
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/30/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/21/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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