MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-08-26 for MTS INCUBATOR MTS9680 manufactured by Microtyping Systems.
[19621595]
The customer immediately took the incubator out of service. The incubator is under warranty and the customer is requesting repair by replacement. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[19685078]
Customer reported that the mts incubator temperature read 44 degrees c during patient testing. The incubator temperature spec is 37 + / - 2 degrees c. The incubator was taken out of use. No erroneous results were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056600-2010-00111 |
| MDR Report Key | 1815542 |
| Report Source | 05,06 |
| Date Received | 2010-08-26 |
| Date of Report | 2010-08-26 |
| Date of Event | 2010-08-23 |
| Date Mfgr Received | 2010-08-23 |
| Device Manufacturer Date | 2006-05-24 |
| Date Added to Maude | 2011-04-18 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. JENNIFER SPARROW |
| Manufacturer Street | 1001 ROUTE 202 |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9082181000 |
| 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 | 2010-08-26 |
| Catalog Number | MTS9680 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTYPING SYSTEMS |
| Manufacturer Address | 1295 SOUTHWEST 29TH AVENUE POMPANO BEACH FL 33069 US 33069 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-26 |