MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-07-17 for MTS INCUBATOR MTS9680 manufactured by Micro Typing Systems, Inc..
[19945072]
Customer discarded the cards that were in the incubator when issue was observed. Investigation conducted regarding the returned mts incubator. The incubator temperature is within specified range. The customer's concern was not confirmed. The customer received a replacement incubator to resolve the issue. (b) (4)
Patient Sequence No: 1, Text Type: N, H10
[19964657]
The customer reported that the temperature of the mts incubator was out of specification. No erroneous results were reported. A temperature out of specification, if undetected during testing may lead to erroneous test results and may lead to the transfusion of incompatible blood.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056600-2009-00150 |
| MDR Report Key | 1481853 |
| Report Source | 05,06 |
| Date Received | 2009-07-17 |
| Date of Report | 2009-07-17 |
| Date of Event | 2009-06-25 |
| Date Mfgr Received | 2009-06-25 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2010-06-08 |
| 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 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JENNIFER SPARROW |
| Manufacturer Street | 1001 US ROUTE 202 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9087043872 |
| 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 | 2009-07-17 |
| Returned To Mfg | 2009-07-02 |
| Model Number | NA |
| Catalog Number | MTS9680 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US 33069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-17 |