MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-12-12 for ORS-331 SLUSH WARMER DRAPE WITH PLATE manufactured by Microtek Dominicana, S.a..
[94824731]
A sample was received for evaluation. A small burn mark/hole was observed about 16 inches from the slush plate. No lot number was provided to perform a device history record review. Based on the sample evaluation this does not appear to be the result of a personnel, process, or material issue. Melts, though uncommon, can occur when the warmer is not draped properly, not turned off by using the power button, and/or there is insufficient fluid in the warmer basin, contrary to the operations manual, product labeling, product insert and in-service presentations. Because this appears to be related to misuse by the customer, no actions are being taken at this time.
Patient Sequence No: 1, Text Type: N, H10
[94824732]
Company rep reported that (b)(6) is stating that they found about an inch of saline in the bottom of the warmer after a surgical case. The hospital received the drape through a cardinal kit. No patient injury or treatment was reported for the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2017-00033 |
| MDR Report Key | 7110751 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-12 |
| Date of Report | 2017-11-03 |
| Date Mfgr Received | 2017-11-03 |
| Date Added to Maude | 2017-12-12 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS JENNIFER MRKVICKA |
| Manufacturer Street | 1 ECOLAB PLACE |
| Manufacturer City | ST. PAUL MN 55102 |
| Manufacturer Country | US |
| Manufacturer Postal | 55102 |
| Manufacturer Phone | 6512502237 |
| Manufacturer G1 | MICROTEK DOMINICANA |
| Manufacturer Street | ZONA FRANCA NO. 2 |
| Manufacturer City | LA ROMANA, |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORS-331 SLUSH WARMER DRAPE WITH PLATE |
| Generic Name | FLUID WARMING AND SLUSH DRAPES |
| Product Code | LHC |
| Date Received | 2017-12-12 |
| Returned To Mfg | 2017-11-09 |
| Model Number | ORS-331 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK DOMINICANA, S.A. |
| Manufacturer Address | ZONA FRANCA NO. 2 LA ROMANA, DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-12 |