MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-16 for CELL-DYN SMS 05H29-04 manufactured by Abbott Diagnostics Division.
[128270444]
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[128270445]
The customer saw sparking on the left back part of the cell-dyn sms (slide maker stainer) system and observed error message, pressure pump failed. The customer stated no smoke or fire (flame) was seen and no exposure or personal injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919069-2018-00056 |
| MDR Report Key | 8081995 |
| Date Received | 2018-11-16 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-10-23 |
| Date Mfgr Received | 2018-12-05 |
| Date Added to Maude | 2018-11-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT DIAGNOSTICS DIVISION |
| Manufacturer Street | 4551 GREAT AMERICA PARKWAY |
| Manufacturer City | SANTA CLARA CA 95054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CELL-DYN SMS |
| Generic Name | AUTOMATED BLOOD FILM PREPARATION AND STAINING |
| Product Code | GKJ |
| Date Received | 2018-11-16 |
| Catalog Number | 05H29-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS DIVISION |
| Manufacturer Address | 4551 GREAT AMERICA PARKWAY SANTA CLARA CA 95054 US 95054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-16 |