MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-09-22 for MTS INCUBATOR MTS9680 manufactured by Micro Typing Systems, Inc..
[633282]
The customer called to report the incubator is reading temps from 36 to 40 degrees. The customer continued to use the incubator despite the out of range temperature (specification is 35 - 39 degrees). The customer claims no samples were compromised.
Patient Sequence No: 1, Text Type: D, B5
[7904658]
The customer claimed no erroneous results were reported. The customer was instructed to discontinue use of the incubator and order a replacement.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2006-00178 |
| MDR Report Key | 870563 |
| Report Source | 05,06 |
| Date Received | 2006-09-22 |
| Date of Report | 2006-09-22 |
| Date of Event | 2006-08-24 |
| Date Mfgr Received | 2006-08-24 |
| Date Added to Maude | 2007-06-26 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVID HAGEN, MGR |
| Manufacturer Street | 1295 SW 29TH AVE |
| Manufacturer City | POMANO BEACH FL 33069 |
| Manufacturer Country | US |
| Manufacturer Postal | 33069 |
| Manufacturer Phone | 9546239528 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTS INCUBATOR |
| Generic Name | INCUBATOR |
| Product Code | JTQ |
| Date Received | 2006-09-22 |
| Model Number | NA |
| Catalog Number | MTS9680 |
| Lot Number | 2250914973 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 851420 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-22 |