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.
[4558305]
It was reported that broken hinges were observed due to the rivets wearing out on the spring load causing failure of the door assembly of the walkaway plus instrument. The spring fell out during opening/closing of the door. No report of the adverse event or injury.
Patient Sequence No: 1, Text Type: D, B5
[12150430]
(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 san francisco district office was notified on 06/09/2014 of the remedial action (report no. 2919016-06/09/14-001-c). A siemens representative will contact the customer over the next few months to schedule a visit to correct this issue with the access door hinge.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2014-00029 |
| MDR Report Key | 3960839 |
| Report Source | 07 |
| Date Received | 2014-06-27 |
| Date of Report | 2014-05-28 |
| Date of Event | 2014-03-28 |
| Date Mfgr Received | 2014-05-28 |
| Date Added to Maude | 2014-08-04 |
| 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 | 9163743031 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2919016-06/09/14-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKAWAY 96 PLUS |
| Generic Name | WALKAWAY 96 PLUS |
| Product Code | LRG |
| Date Received | 2014-06-27 |
| Catalog Number | B1018-284 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-27 |