MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for MAXI-THERM LITE 874 82874 manufactured by Cincinnati Subzero Products, Llc (csz Medical).
[145368673]
Baby required total body cooling for hypoxic ischemic encephalopathy (hie). When attaching cooling blanket to cooling machine and starting to run the water through, the blanket started leaking. Hoses clamped off and blanket detached and replaced with new blanket.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8619296 |
| MDR Report Key | 8619296 |
| Date Received | 2019-05-17 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-04-07 |
| Report Date | 2019-04-12 |
| Date Reported to FDA | 2019-04-12 |
| Date Reported to Mfgr | 2019-05-17 |
| Date Added to Maude | 2019-05-17 |
| 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 | 2019-05-17 |
| Model Number | 874 |
| Catalog Number | 82874 |
| Lot Number | 748019 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CINCINNATI SUBZERO PRODUCTS, LLC (CSZ MEDICAL) |
| Manufacturer Address | 12011 MOSTELLER RD. CINCINNATI OH 45241 US 45241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-17 |