MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-09-20 for ORS-331 SLUSH WARMER DRAPE WITH PLATE manufactured by Microtek Dominicana, S.a..
[88233360]
A sample was received for evaluation. During visual inspection, a hole was not found. The drape was placed over a warmer and about two liters of water were added to the basin to check for leaks. No leaks were found. No lot number was not provided for this complaint; therefore, a device history record could not be performed. Since the sample review did not confirm the non conformity, this does not appear to be the result of a personnel, process or material issue and the investigation is inconclusive. No further actions will be taken at this time.
Patient Sequence No: 1, Text Type: N, H10
[88233361]
Cardinal is reporting that (b)(6) medical center has notified them of a hole in ors-331 that comes in a cardinal open heart pack. They indicated that the hole was on the warmer side of the drape. No patient injury or treatment was reported for the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2017-00027 |
| MDR Report Key | 6878911 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-09-20 |
| Date of Report | 2017-08-21 |
| Date Mfgr Received | 2017-08-21 |
| Date Added to Maude | 2017-09-20 |
| 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 | 2017-09-20 |
| Returned To Mfg | 2017-08-30 |
| 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 | 2017-09-20 |