WALKAWAY 96 PLUS B1018-284

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-06-27 for WALKAWAY 96 PLUS B1018-284 manufactured by Siemens Healthcare Diagnostics.

Event Text Entries

[4558304] It was reported that the pin that holds the pivot pin on the hinge was intact but the spring was no longer there and likely popped out while the door was closed. The spring was found in the access door area. No damage to the interior of the walkaway plus instrument. No report of adverse event or injury.
Patient Sequence No: 1, Text Type: D, B5


[12150429] (b)(4). Product quality issue associated with an inherent device and/or device component characteristic that is not satisfactory as specific or delivered. Siemens healthcare diagnostics inc. Conducted a field correction, internal number (b)(4). A written customer notification was sent on 06/2014 to all customers affected notifying them of the springs contained in the access door hinge assembly on the walkaway plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue fort the customer. The notification also includes actions to be taken by customers. The fda (b)(4) district office was notified on 06/09/2014 of the remedial action (report no. 2919016-06/09/14-001-c). Siemens customer service engineer replaced the access door and the walkaway plus instrument is up and running.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2919016-2014-00026
MDR Report Key3960837
Report Source07
Date Received2014-06-27
Date of Report2014-05-28
Date of Event2014-03-14
Date Mfgr Received2014-05-28
Date Added to Maude2014-08-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJOSE UNTALAN
Manufacturer Street2040 ENTERPRISE BLVD.
Manufacturer CityWEST SACRAMENTO CA 95691
Manufacturer CountryUS
Manufacturer Postal95691
Manufacturer Phone9163743031
Single Use3
Remedial ActionNO
Previous Use Code3
Removal Correction Number2919016-06/09/14-001-C
Event Type3
Type of Report3

Device Details

Brand NameWALKAWAY 96 PLUS
Generic NameWALKAWAY 96 PLUS
Product CodeLRG
Date Received2014-06-27
Catalog NumberB1018-284
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS
Manufacturer AddressWEST SACRAMENTO CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2014-06-27

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