MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-23 for WALKAWAY 96 PLUS N/A B1018-284 manufactured by Beckman Coulter.
[22953313]
The walkaway plus not powering up was likely due to the incorrect wiring of the originally installed power adapter. The original power adapter has been requested for return to the manufacturer for further evaluation. The electrical short was likely a result of using the power adapter from a different instrument model from the manufacturer. Review of the photo submitted revealed that the orange and blue power cables (primary line of the transformer) in the instrument were burnt. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[22953316]
It was reported that the walkaway plus instrument would not power up during installation. The manufacturer field service engineer replaced the power adapter from a different instrument model from the manufacturer. When the walkaway plus instrument was powered up, smoke and burning smell was observed. An electrical short occurred damaging the cables of the instrument.
Patient Sequence No: 1, Text Type: D, B5
[30226941]
The power adaptor was returned for investigation. The investigation revealed it does not match the manufacturer's drawing specification. It is possible the part was assembled and/or wired incorrectly. A new walkaway plus instrument was delivered to the customer. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2015-00097 |
| MDR Report Key | 4937443 |
| Date Received | 2015-07-23 |
| Date of Report | 2015-06-25 |
| Date of Event | 2015-06-25 |
| Date Mfgr Received | 2015-09-23 |
| Device Manufacturer Date | 2015-02-17 |
| Date Added to Maude | 2015-07-23 |
| 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 | SERVICE AND TESTING PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NORMA RAHILL |
| Manufacturer Street | 1584 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163742139 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 2040 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95691 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKAWAY 96 PLUS |
| Generic Name | INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS |
| Product Code | LRG |
| Date Received | 2015-07-23 |
| Model Number | N/A |
| Catalog Number | B1018-284 |
| Lot Number | N/A |
| Operator | SERVICE AND TESTING PERSONNEL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 2040 ENTERPRISE BLVD WEST SACRAMENTO CA 95691 US 95691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-23 |