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 2018-04-30 for WARMER DRAPE WITH SKIRT ORS-188231 manufactured by Microtek Dominicana, S.a..
[107457888]
A sample was received for evaluation. The drape was decontaminated then placed over a warmer. Water was poured into the warmer and left overnight. There was water in the basin under the drape. A small burn mark with a very small, unnoticeable hole was found. The dhr was reviewed and it was confirmed that lot d172213 had (b)(4) cases that were manufactured from 08/10/2017 to 08/13/2017. No defects were reported during quality inspections. Based on the device history record and sample review, 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
[107457889]
Operating room (or) techs said there was fluid under the drape following a surgery it was used on. They said that the fluid levels in the warmer were kept at appropriate levels throughout the case. No patient injury or treatment was reported for the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2018-00013 |
| MDR Report Key | 7474265 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-30 |
| Date of Report | 2018-04-13 |
| Date Mfgr Received | 2018-04-13 |
| Date Added to Maude | 2018-04-30 |
| 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 | WARMER DRAPE WITH SKIRT |
| Generic Name | FLUID WARMING AND SLUSH DRAPES |
| Product Code | LHC |
| Date Received | 2018-04-30 |
| Returned To Mfg | 2018-04-17 |
| Model Number | ORS-188231 |
| Lot Number | D172213 |
| 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 | 2018-04-30 |