MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-11-13 for MTS INCUBATOR MTS9680 manufactured by Micro Typing Systems, Inc..
[728923]
The customer indicated that the incubator generated smoke. The customer had a 3 gallon container of saline above the incubator. The saline leaked inside the incubator and melted the circuit board inside causing smoke to generate from the inside. No fire or shock reported as a result of this incident. No death or serious injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[7902389]
User error identified as root cause. Saline leaked inside incubator. Product labeling states "do not pour liquid over the instrument. " (mts incubator user's guide 2004-06-30 p. 9) assistance provided to the customer over the phone has resolved the issue. Instrument has been removed from service and disposed by customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2007-00313 |
| MDR Report Key | 942952 |
| Report Source | 05,06 |
| Date Received | 2007-11-13 |
| Date of Report | 2007-11-13 |
| Date of Event | 2007-10-19 |
| Date Mfgr Received | 2007-10-19 |
| Device Manufacturer Date | 2002-06-01 |
| Date Added to Maude | 2008-01-08 |
| 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 | AWILDA GERBER, ASSOC III |
| Manufacturer Street | 1295 S.W. 29TH AVE. |
| Manufacturer City | POMPANO BEACH FL 33069 |
| Manufacturer Country | US |
| Manufacturer Postal | 33069 |
| Manufacturer Phone | 9546239567 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTS INCUBATOR |
| Generic Name | MTS GEL CARD INCUBATOR |
| Product Code | JTQ |
| Date Received | 2007-11-13 |
| Model Number | NA |
| Catalog Number | MTS9680 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 938044 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-13 |