MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-11-13 for CONMED I.V. CONTROLLER S2V-60 U manufactured by Conmed Corp..
[77119]
It was reported that the pt suddenly developed a blood pressure of 260 without reason. Large amounts of anesthetic drugs both intravenous and inhaled as well as a huge dose of intravenous nitroglycerin was given without immediate effect. Intravenous esmolol was utilized and the pressure gradually came down. During this time it was noted that a phenylephrine drip which had been placed in line but removed during the hypertensive crisis, was controlled by a conmed iv controller and was noted to be dripping in the "off" position. A hlth care professional noted that this was a life threatening complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317214-1997-00147 |
| MDR Report Key | 131313 |
| Report Source | 05,06 |
| Date Received | 1997-11-13 |
| Date of Report | 1997-10-14 |
| Date of Event | 1997-10-14 |
| Date Facility Aware | 1997-10-14 |
| Report Date | 1997-10-14 |
| Date Mfgr Received | 1997-10-14 |
| Date Added to Maude | 1997-11-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONMED I.V. CONTROLLER |
| Generic Name | I.V. CONTROLLER |
| Product Code | LDR |
| Date Received | 1997-11-13 |
| Model Number | NA |
| Catalog Number | S2V-60 U |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 128351 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | 310 BROAD ST. UTICA NY 13501 US |
| Baseline Brand Name | CONMED I.V. CONTROLLER |
| Baseline Generic Name | I.V. CONTROLLER |
| Baseline Model No | NA |
| Baseline Catalog No | S2V-60 U |
| Baseline ID | * |
| Baseline Device Family | I.V. PRODUCTS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K964844 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-11-13 |