MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-01-30 for WALKAWAY 40 PLUS B1015-283 B1018-283 manufactured by Siemens Healthcare Diagnostics.
[21239570]
The top spring broke off from the panel access door hinge and was discovered by the manufacturer's customer service engineer at the bottom of the walkaway system. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
[21373058]
(b)(4). Issue associated with an inherent device and/or device component characteristic that is not satisfactory as specified or delivered. Conclusion: device not returned (b)(4) on 01/14/2015, the manufacturer customer service engineer (cse) was on site to resolve the issue on a separate complaint regarding the complaint of spring broke off from the panel access door hinge. Cse reviewed the parts provided by the customer and determined that these parts were not from the hinges but from the door latching mechanism attached to the left side of the door. The customer also clarified that the part (which was the latch adjustment screw) was the one that fell out of the instrument and was not ejected. Photos of the upper and lower hinges of the panel access door provided was also provided. Review of these photos revealed that one of the hinges was missing a spring. The interior of the walkaway system was searched and found the spring at the bottom of the system. On 01/15/2015, cse replaced the panel access door. The defective parts have not been returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2015-00004 |
| MDR Report Key | 4482361 |
| Report Source | 05,07 |
| Date Received | 2015-01-30 |
| Date of Report | 2015-01-14 |
| Date of Event | 2015-01-14 |
| Date Mfgr Received | 2015-01-14 |
| Date Added to Maude | 2015-03-05 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKAWAY 40 PLUS |
| Generic Name | WALKAWAY 40 PLUS |
| Product Code | LRG |
| Date Received | 2015-01-30 |
| Model Number | B1015-283 |
| Catalog Number | B1018-283 |
| 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 | 2015-01-30 |