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.
[4757227]
During the report described in mdr# 2919016-2014-00035, the customer added new information for an issue which occurred on (b)(6) 2014. The customer reported that the hinge had flown out of the instrument and the user had been struck in the chest. The user was not injured and no medical intervention was required or performed. This was originally reported on (b)(6) 2014 as the upper panel access door hinge failure.
Patient Sequence No: 1, Text Type: D, B5
[12199049]
(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 authorized representative replaced the defective door assembly. System check was performed and the instrument was found to be operational and performing to specification. 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 june 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 06/09/2014 of the remedial action (report no. 2919016 - 06/09/2014-001-c). On 08/13/2014, siemens representative has confirmed that appropriate modifications to the hinge was performed. Customer confirmed the system's performance and reported that it is fully operational.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2014-00034 |
| MDR Report Key | 4102309 |
| Report Source | 05 |
| Date Received | 2014-08-27 |
| Date of Report | 2014-08-12 |
| Date of Event | 2014-04-10 |
| Date Mfgr Received | 2014-08-12 |
| Date Added to Maude | 2014-09-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOSE UNTALAN |
| Manufacturer Street | 2040 ENTERPRISE BLVD. |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9143743031 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1990-2014 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WA96 PLUS |
| Generic Name | WALKAWAY 96 PLUS |
| Product Code | LRG |
| Date Received | 2014-08-27 |
| Model Number | B1018-284 |
| Catalog Number | B1018-284 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | WEST SACRAMENTO CA 95691 US 95691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-27 |