MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-10-12 for ORS-100 FLUID WARMER DRAPE manufactured by Microtek Dominicana, S.a..
[90307834]
A sample was received for evaluation. The sample drape had a small burn mark/hole about three inches from the center of the drape. The dhr was reviewed for lot d171141 and it was noted that this lot had (b)(4) pcs that were manufactured on 04/24/2017. No defects were reported during quality inspections. Based on the dhr and sample review this issue 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
[90307835]
End user reported that water was found in the basin of an ors irrigation fluid warmer following the completion of an ortho case. End user stated that no sharps were introduced into the drape/basin during the case. No patient injury or treatment were reported for the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2017-00028 |
| MDR Report Key | 6946450 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-10-12 |
| Date of Report | 2017-09-15 |
| Date of Event | 2017-09-11 |
| Date Mfgr Received | 2017-09-15 |
| Date Added to Maude | 2017-10-12 |
| 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-100 FLUID WARMER DRAPE |
| Generic Name | FLUID WARMING AND SLUSH DRAPES |
| Product Code | LHC |
| Date Received | 2017-10-12 |
| Returned To Mfg | 2017-10-02 |
| Model Number | ORS-100 |
| Lot Number | D171141 |
| 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 | 2017-10-12 |