MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-18 for CONTROLLER ONLY S2 manufactured by Consolidated Medical Equipment.
[145371613]
The reported device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[145371614]
This distributor reported on behalf of their customer that the s2 device had a low flow rate during pre-op testing. It was not determined if the pre-op testing occurred inside or outside the sterile field. There was no report of injury to user or any type of patient involvement. Further assessment information was requested; however, to date, no further information has been obtained. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2019-00134 |
| MDR Report Key | 8528394 |
| Date Received | 2019-04-18 |
| Date of Report | 2019-05-14 |
| Date Mfgr Received | 2019-05-13 |
| Device Manufacturer Date | 2017-10-20 |
| Date Added to Maude | 2019-04-18 |
| 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 | MR. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995358 |
| Manufacturer G1 | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Street | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA, 31136 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 31136 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CONTROLLER ONLY |
| Generic Name | CONTROLLER, INFUSION, INTRAVASCULAR, ELECTRONIC |
| Product Code | LDR |
| Date Received | 2019-04-18 |
| Returned To Mfg | 2019-04-10 |
| Catalog Number | S2 |
| Lot Number | 201710205 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Address | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA, 31136 MX 31136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-18 |