MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-02-05 for ORS-100 FLUID WARMER DRAPE manufactured by Microtek Dominicana, S.a..
[99780872]
A sample was received for evaluation. Three burn marks/holes were observed on the drape. The first burn mark/hole was about 1/2 inch from the center of the drape, the second burn mark/hole was about 1 1/2 inches away from the center of the drape and the third was about 2 inches from the center of the drape. The dhr was reviewed and it was noticed that this lot had (b)(4) cases that were manufactured from 02/20/2017 to 02/21/2017. No defects related to the non conformance were reported during quality inspections. Based on the device history record and sample review, the malfunction 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
[99780873]
A medwatch form was received on 1/12/2018 with the following information: "irrigation warmer drape had a hole that allowed the irrigation to come in contact with unsterile surface. This was brought to surgeon's attention during a chiari decompression surgery. " no adverse event was reported for the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2018-00003 |
| MDR Report Key | 7242296 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-05 |
| Date of Report | 2018-01-12 |
| Date of Event | 2017-05-24 |
| Date Mfgr Received | 2018-01-12 |
| Date Added to Maude | 2018-02-05 |
| 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 | 2018-02-05 |
| Returned To Mfg | 2018-01-30 |
| Model Number | ORS-100 |
| Lot Number | D170511 |
| 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 | 2018-02-05 |