MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-29 for INTRATEMP ITW6L manufactured by Microtek Medical, Inc..
[112746964]
The basin fluid warmer side pockets became very hot yet the digital display indicated 107 degrees f. The two side "bottle pockets" are not to exceed 110 degrees f. We have found that the bottle temperature can reach 130 degrees f when the bottle is not resting over the temperature sensor. Various size solution bottles may be placed into these pockets. The smaller bottles can be placed in the pocket such that it is not resting over the temperature sensor. When the sensor is not touching the side of the solution bottle it overheats the bottle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7650768 |
| MDR Report Key | 7650768 |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-05-31 |
| Report Date | 2018-06-06 |
| Date Reported to FDA | 2018-06-06 |
| Date Reported to Mfgr | 2018-06-29 |
| Date Added to Maude | 2018-06-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRATEMP |
| Generic Name | WARMER, IRRIGATION SOLUTION |
| Product Code | LHC |
| Date Received | 2018-06-29 |
| Model Number | ITW6L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK MEDICAL, INC. |
| Manufacturer Address | 13000 DEERFIELD PARKWAY, SUITE 300 ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-29 |