MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-03-18 for UNSPECIFIED BIS PRODUCT manufactured by Jabil Circuit Singapore Pte Ltd.
[184086305]
Title misinterpretation and limitations of peeg monitoring during multimodal general anesthesia: a case report. [report] source a<(>&<)>a practice, volume 14, 2020(109-11) article number: 4 date of publication: 15feb 2020. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184086306]
According to literature source of study performed, during the maintenance phase of multimodal general anesthesia in a patient monitored with bilateral bis. A (b)(6) year-old male patient (90 kg, 1. 77 m) with hypertension and colon cancer presented for laparoscopic colectomy. The surgery lasted for 4 hours 20 minutes. Nearly 3 hours 30 minutes after induction, values were between 30 and 40 and a downward trend was observed. The spectrogram showed a progressive dissipation of its alpha oscillation pattern for approximately 30 minutes. Suddenly, the heart rate rose from 60 to 90 beats per minute and the systolic blood pressure from 100 to 190 mm hg accompanied by a rise in bis values from 35 to 74 and spectral edge frequency from 12 to 25 hz. Nearly 30 minutes later, bis values progressively increased, and sr went from 0 to 8 before recovery of consciousness. It was expected that an increase in sr would be accompanied by a decrease in bis. In this case, a simultaneous increase in bis values and sr was observed. At the end of the procedure, the patient was transferred to the post anesthesia care unit. No spontaneous recall of the event was reported article title: misinterpretation and limitations of peeg monitoring during multimodal general anesthesia: a case report published: 15 february 2020
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00209 |
| MDR Report Key | 9847285 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2019-11-25 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-18 |
| 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 | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | JABIL CIRCUIT SINGAPORE PTE LTD |
| Manufacturer Street | 1 UPLAND RD |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02062 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNSPECIFIED BIS PRODUCT |
| Generic Name | ELECTRODE, CUTANEOUS |
| Product Code | GXY |
| Date Received | 2020-03-18 |
| Model Number | UNSPECIFIED BIS PRODUCT |
| Catalog Number | UNSPECIFIED BIS PRODUCT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JABIL CIRCUIT SINGAPORE PTE LTD |
| Manufacturer Address | 1 UPLAND RD NORWOOD MA 02062 US 02062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |