MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-02 for WALKAWAY96 N/A B1018-284 manufactured by Beckman Coulter.
[5556779]
It was reported the walkaway 96 plus had a spring came loose from the hinge of the panel access door and fell out into pieces. The customer was able to open and close the door without problems after the event. There was no death, injury or change to patient treatment. No erroneous results were generated in connection with the reported event.
Patient Sequence No: 1, Text Type: D, B5
[12937322]
The field service engineer (fse) repaired the hinge component and verified that the service hatch door was fully functional. A review of the service history for this instrument suggests that the door assembly had been replaced in (b)(4) 2013. A field action msi 14-01 (fda z-1990-2014) was issued on june 2014 for this type of failure. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2015-00005 |
| MDR Report Key | 4561348 |
| Report Source | 05,06 |
| Date Received | 2015-03-02 |
| Date of Report | 2015-02-02 |
| Date of Event | 2015-02-02 |
| Date Mfgr Received | 2015-02-02 |
| Date Added to Maude | 2015-04-01 |
| 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 G1 | BECKMAN COULTER |
| Manufacturer Street | 2040 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95691 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1990-2014 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKAWAY96 |
| Generic Name | INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS |
| Product Code | LRG |
| Date Received | 2015-03-02 |
| Model Number | N/A |
| Catalog Number | B1018-284 |
| Lot Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-03-02 |