MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-01 for TDXFLX SYSTEM 04A24-96 manufactured by Abbott Manufacturing Inc.
[41920729]
(b)(4) review by the abbott field service engineer (fse) identified the source of the smoke as a dirty air heater assembly. A clogged fan with gasket was also replaced to return the analyzer to normal function. The observed damage was limited to the air heater assembly and did not spread to other parts of the analyzer. Further evaluation of the customer issue included a review of the complaint text, a search for similar complaints, and a review of labeling. Return parts were not available. Review of the service history, for instrument serial number (b)(4), did not identify any other issues that may have contributed to the current complaint issue. A tracking and trending review was completed; no adverse trend for smoke/burn complaints of the fan with gasket was identified. Labeling was reviewed and it was determined that adequate instructions, as to the specific requirements for safe and optimum performance of the system, which includes leaving the instrument power on continuously and allowing for adequate ventilation. Instructions for performing an emergency shutdown are also provided. Based on the available information no product deficiency air heater assembly of the tdxflx, list number 04a24, was identified.
Patient Sequence No: 1, Text Type: N, H10
[41920730]
The customer observed smoke while using the tdxflx analyzer. The customer indicated that when turned the analyzer back on, after cleaning the air filter, a puff of smoke was visible and inside the carousel was warm. No injuries or impact to patient management were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1628664-2016-00084 |
| MDR Report Key | 5541570 |
| Date Received | 2016-04-01 |
| Date of Report | 2016-04-01 |
| Date of Event | 2016-03-10 |
| Date Mfgr Received | 2016-03-10 |
| Date Added to Maude | 2016-04-01 |
| 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 |
| 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 MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TDXFLX SYSTEM |
| Generic Name | AUTOMATED FLUORESCENT IMMUNOASSAY ANALYZER |
| Product Code | JJQ |
| Date Received | 2016-04-01 |
| Catalog Number | 04A24-96 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-01 |