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 2018-02-08 for ORS-320 SLUSH WARMER DISC DRAPE manufactured by Microtek Dominicana, S.a..
[99935602]
The sample was received for evaluation. The customer had marked what they described as a break on the slush side of the unit near the disk. The drape was tested with water on both sides of the unit, slush and warmer side, and no leaks were found. The dhr was reviewed for this lot and it was observed that (b)(4) cases were manufactured from 03/28/2017 to 03/31/2017. No defects were reported during quality inspections. Based on the device history record and the sample review, this does not appear to be the result of a personnel, process or material issue. It is normal for a small amount of liquid to collect in the basin due to condensation. After use, dry the basin with a lint-free cloth and isopropyl alcohol. Refer to operations manual for the ors-1075hs and ors-1058hs hush slush surgical slush systems. Since it is normal for liquid to be in the slush basin due to condensation and the non conformity was not found during the sample review, no further actions will be taken.
Patient Sequence No: 1, Text Type: N, H10
[99935603]
Sales rep received an email from the hospital on (b)(6) 2018 stating that during a recent ct surgical case, water was found underneath the ors-320 drape. Customer stated that nothing was introduced into the basin that would cause a hole or a tear. Hospital personnel located the breach and marked it on the drape, along with tying a suture around it. During a ce presentation at the hospital on (b)(6) 2018, the operating room resource nurse asked the rep if they had the drape. Rep replied he had picked it up. He was then told that they do put items into the basin that they shouldn't. No patient injury or treatment was reported for the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2018-00005 |
| MDR Report Key | 7251271 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-08 |
| Date of Report | 2018-01-18 |
| Date of Event | 2018-01-17 |
| Date Mfgr Received | 2018-01-18 |
| Date Added to Maude | 2018-02-08 |
| 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-320 SLUSH WARMER DISC DRAPE |
| Generic Name | FLUID WARMING AND SLUSH DRAPES |
| Product Code | LHC |
| Date Received | 2018-02-08 |
| Returned To Mfg | 2018-02-02 |
| Model Number | ORS-320 |
| Lot Number | D170871 |
| 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 | 2018-02-08 |