MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-27 for MAXI-THERM?LITE 874 82874 manufactured by Cincinnati Sub-zero Products, Inc..
[115221059]
Cooling blanket was being used as part of total body cooling system. Blanket malfunctioned and did not maintain the programmed temperature. Cooling blanket was removed and replaced by a new cooling blanket.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7725932 |
| MDR Report Key | 7725932 |
| Date Received | 2018-07-27 |
| Date of Report | 2018-07-09 |
| Date of Event | 2018-06-28 |
| Report Date | 2018-07-09 |
| Date Reported to FDA | 2018-07-09 |
| Date Reported to Mfgr | 2018-07-27 |
| Date Added to Maude | 2018-07-27 |
| 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 | MAXI-THERM?LITE |
| Generic Name | PACK, HOT OR COLD, WATER CIRCULATING |
| Product Code | ILO |
| Date Received | 2018-07-27 |
| Model Number | 874 |
| Catalog Number | 82874 |
| Lot Number | 747313 |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CINCINNATI SUB-ZERO PRODUCTS, INC. |
| Manufacturer Address | 12011 MOSTELLER RD CINCINNATI OH 45241 US 45241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-27 |