WA96 PLUS B1018-284

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-27 for WA96 PLUS B1018-284 manufactured by Siemens Healthcare Diagnostics.

Event Text Entries

[4757715] It was reported that the lower panel access door hinge failed. The hinge pin appeared to have fallen out and the spring fell when the panel access door was opened. No injury or adverse event occurred.
Patient Sequence No: 1, Text Type: D, B5


[12177558] (b)(4). Product quality issue associated with an inherent device and/or device component characteristics that is not satisfactory as specific or delivered. Method: actual device not evaluated. Results: no results available since no evaluation performed. Conclusions: device not returned. Siemens healthcare diagnostics inc. Conducted a field correction, internal number (b)(4) on the issue with the access door hinge. A written customer notification was sent on (b)(4) 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 for the customer. The notification also includes actions to be taken by the customers. The fda san francisco district office was notified on june 9, 2014 of the remedial action (report no. 2919016-06/09/14-001-c). On (b)(4) 2014, siemens representative has confirmed that appropriate modifications to the hinge were performed. Customer confirmed the system's performance and reported that it is fully functional.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2919016-2014-00035
MDR Report Key4102326
Report Source05
Date Received2014-08-27
Date of Report2014-08-12
Date of Event2014-08-12
Date Mfgr Received2014-08-12
Date Added to Maude2014-09-26
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 Phone9143743031
Single Use3
Remedial ActionNO
Previous Use Code3
Removal Correction NumberZ-1990-2014
Event Type3
Type of Report3

Device Details

Brand NameWA96 PLUS
Generic NameWALKAWAY 96 PLUS
Product CodeLRG
Date Received2014-08-27
Model NumberB1018-284
Catalog NumberB1018-284
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS
Manufacturer AddressWEST SACRAMENTO CA 95691 US 95691


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.