FDA.reportPublic FDA data

MAUDE MDR 6752856

MDR report key
6752856
Report number
2031172-2017-00737
Event key
0
Event type
3
Date of event
2017-07-01
Date received
2017-07-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STEFAN LISSMANN
Address
52 DISCOVERY IRVINE CA 92618 US
Phone
949-949-9492
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SEDLINEELECTROENCEPHALOGRAPHMASIMO - 40 PARKERGWQ24792479R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-280

Event Narratives#

N

Patient 1

(IF OTHER): IT WAS INDICATED BY THE CUSTOMER THAT THE SENSOR USED DURING THE REPORTED EVENT HAS BEEN DISCARDED; AND THEREFORE, COULD NOT BE RETURNED TO MASIMO FOR EVALUATION. IF NEW INFORMATION IS OBTAINED OR THE PRODUCT IS RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(6):

D

Patient 1

THE CUSTOMER REPORTED WHILE PERFORMING A MASTECTOMY PSI WAS 20-21 DURING INTUBATION, SO DR. (B)(6) THOUGHT THE DEPTH OF ANESTHESIA WAS FINE. HOWEVER, SUDDENLY HR WENT UP. THEREFORE, HE INCREASED DOSE OF REMIFENTANIL. AFTER SURGERY HE ASKED THE PATIENT ABOUT INTUBATION. SHE WAS NOT SUFFERED FROM INTUBATION BUT REMEMBERED ABOUT INTUBATION. (SHE DID NOT OPEN HER EYES BECAUSE OF MUSCLE RELAXANT.) HE ASKED POSSIBLE REASON WHY PSI WAS BELOW 25 EVEN, SHE REMEMBERED THIS EVENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.