MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-08-30 for TDX FPIA ANALYZER 9520-03 manufactured by Abbott Manufacturing, Inc.
[727526]
The customer states that the tdx fpia analyzer generated error code "a htr brk fail" accompanied by smoke and a burning smell. The instrument was powered off and unplugged. The operator followed the emergency shutdown procedure. No one was injured and no damage was done to the surrounding environment. The customer is requesting a service call. There in no impact to pt management reported.
Patient Sequence No: 1, Text Type: D, B5
[7858163]
The field service representative (fsr) replaced the tdx analyzer's air heater, insulator, thermistor, fan and fan filter. The fan and air heater were found to be clogged/obstructed. The fsr also performed a boom calibration, temperature verification, photo calibration and checked and adjusted the air set from 33 to 31. All the checks and calibrations passed and the instrument was returned to the customer for operation. There has been no further issues documented. The tdx systems operations manual section vi, troubleshooting, displayed error codes, a h htr brk fail, provides adequate instruction for the customer. A possible cause for the error is the air heater continues to remain above specification for a period of time. The customer is instructed to contact the customer support center immediately. Section i, system description, operational precautions and limitations, instructs the operator to keep the analyzer out of direct sunlight, drafts, and away from sources of direct heat and moisture. The emergency shutdown procedure instructs the operator to turn off the analyzer, and disconnect the power cord prior to servicing. Section v, maintenance, weekly, instructs the operator to clean the air-fan filter weekly. The investigation demonstrated that the tdx fpia analyzer is performing within its intended use, label claims and specifications. No deficiency related to the performance of the device was identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2007-00403 |
| MDR Report Key | 906952 |
| Report Source | 05 |
| Date Received | 2007-08-30 |
| Date of Report | 2007-08-01 |
| Date of Event | 2007-08-01 |
| Date Mfgr Received | 2007-08-01 |
| Device Manufacturer Date | 1988-12-01 |
| Date Added to Maude | 2007-11-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK RD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TDX FPIA ANALYZER |
| Generic Name | AUTOMATED FPIA ANALYZER |
| Product Code | LCQ |
| Date Received | 2007-08-30 |
| Model Number | NA |
| Catalog Number | 9520-03 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 900234 |
| Manufacturer | ABBOTT MANUFACTURING, INC |
| Manufacturer Address | 1921 HURD DR. IRVING TX 75038 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-30 |