MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-06-02 for WALKAWAY 40 PLUS N/A B1018-283 manufactured by Beckman Couler.
[5833012]
It was reported that the spring from the panel access door hinge "popped" out and landed on the counter when the user was accessing the walkaway instrument. The exact date of event was unknown however it was reported that it occurred several months ago. It was reported that the user was not wearing safety glasses for eye protection other than regular glasses. There was no report of injury due to this incident.
Patient Sequence No: 1, Text Type: D, B5
[13389277]
A field action was issued on june 2014 for this type of failure and filed with the fda per report number z-1990-2014. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2015-00073 |
| MDR Report Key | 4813353 |
| Report Source | 05,06 |
| Date Received | 2015-06-02 |
| Date of Report | 2015-05-04 |
| Date of Event | 2015-05-04 |
| Date Mfgr Received | 2015-05-04 |
| Device Manufacturer Date | 2012-06-15 |
| Date Added to Maude | 2015-06-30 |
| 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 | 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 | Z-1990-2014 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKAWAY 40 PLUS |
| Generic Name | INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS |
| Product Code | LRG |
| Date Received | 2015-06-02 |
| Model Number | N/A |
| Catalog Number | B1018-283 |
| Lot Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULER |
| Manufacturer Address | 2040 ENTERPRISE BLVD WEST SACRAMENTO CA 95691 US 95691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-02 |