MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-12-15 for S2 CONTROLLER ONLY manufactured by Consolidated Medical Equipment Company.
[95792729]
The reported devices are being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the devices evaluation and complaint investigation.
Patient Sequence No: 1, Text Type: N, H10
[95792730]
Upon incoming inspection the distributor reported that the s2 pumpette controllers, 30 units, were not suitable for use. The distributor found the rate not to be accurate, as the flow rate was below the printed scales. This was found before any patient contact; therefore, no patient injury was reported. This report is raised on the basis of a reported malfunction with potential for patient injury with recurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2017-00277 |
| MDR Report Key | 7121502 |
| Report Source | OTHER |
| Date Received | 2017-12-15 |
| Date of Report | 2017-12-22 |
| Date Mfgr Received | 2017-12-22 |
| Device Manufacturer Date | 2017-08-03 |
| Date Added to Maude | 2017-12-15 |
| 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. MARTHA CAMACHO URRIBARRI |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243051 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 135025994 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | S2 CONTROLLER ONLY |
| Generic Name | S2 |
| Product Code | LDR |
| Date Received | 2017-12-15 |
| Returned To Mfg | 2017-12-20 |
| Catalog Number | S2 |
| Lot Number | 201708034 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSOLIDATED MEDICAL EQUIPMENT COMPANY |
| Manufacturer Address | AVE. ALEJANDRO DUMAS NO. 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA CP 1136 MX CP 1136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-15 |