MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LCA PCA REFURB 802.11; 80MEA

Catalog Number 20709

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2014

Event Type  malfunction  

Event Description

The customer contact reported during preventive maintenance testing at the user facility, an e630 (screw rotation error) error code was noted and the device did not pass the rotation test in the biomed mode.There were no reports of any adverse pt events or delays in critical therapies while the device was in clinical use.No add'l info was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been rec'd.This report represents all the info known by the rptr upon query by hospira personnel.

• Brand Name: LCA PCA REFURB 802.11
• 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 Key: 3821150
• MDR Text Key: 21730093
• Report Number: 9615050-2014-02738
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2014

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: Health Professional
• Device Catalogue Number: 20709
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2014
• Initial Date FDA Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1