MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-06 for HIGHT THROUGHTPUT AUTOMATION manufactured by Hologic.
[15016255]
Upon starting instrument customer experienced a strong burning rubber smell, called technical support, and turned off the instrument. No person was injured in this event and there was no delay in or impact to patient diagnosis. Customer confirmed that no medical attention was needed by laboratory technicians with respect to this event. According to the supplier of the component involved in this event, the circuit board involved was developed in compliance with (b)(4) and the requirement that overheated pcb may not burn and cause spreading fire was fulfilled and confirmed by in-house testing. Root cause of this event is under investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2013-00024 |
| MDR Report Key | 2958086 |
| Report Source | 05 |
| Date Received | 2013-02-06 |
| Date of Report | 2013-01-10 |
| Date of Event | 2013-01-10 |
| Date Added to Maude | 2013-04-22 |
| 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 | RANDALL COVILL, MGR. |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638853 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGHT THROUGHTPUT AUTOMATION |
| Generic Name | HTA |
| Product Code | MAQ |
| Date Received | 2013-02-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-06 |