FDA.reportPublic FDA data

MAUDE MDR 2366289

MDR report key
2366289
Report number
3005844579-2011-00001
Event key
0
Event type
3
Date of event
2011-09-01
Date received
2011-12-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
9351 GRANT ST STE 600 THORNTON CO 80229 US
Phone
303-303-3039
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EMBLA S7000S7000 BEDSIDE UNITEMBLA SYSTEMS, INC.MNRS70002000202R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-12-0701. L

Event Narratives#

D

Patient 1

DURING A SLEEP STUDY FOR A (B)(6) CHILD, THE NURSE'S STATION WAS ALERTED THAT THE DEVICE HAD BECOME DISCONNECTED. WHEN THE NURSE WENT TO CHECK ON THE PT, SHE FOUND THAT THE LEAD CABLE ATTACHED TO THE EMBLA WALL UNIT WAS WRAPPED TIGHTLY AROUND THE PT'S NECK TWICE. THE PT WAS VERY RESTLESS DURING THE NIGHT AND NURSING STAFF HAD ENTERED THE ROOM REGULARLY TO ADJUST THE PULSE OXIMETER PROBE. NO INJURY AND PT WAS ASSESSED AND OBSERVATIONS WERE WITHIN NORMAL LIMITS FOR AGE OF CHILD. EXTRA OBSERVATION OF PT BY NURSING.

N

Patient 1

THERE ARE ALWAYS TYPICAL RISKS ASSOCIATED WITH ANY CABLED DEVICE WHEN IN USE WITH PEDIATRIC PTS. DUE TO THIS RISK, EMBLA HAD ADDED A CAUTIONARY STATEMENT TO THE INSTRUCTIONS FOR USE FOR THE EMBLA S7000 DEVICE. CAUTIONARY STATEMENT READS, "CAUTION MUST BE TAKEN TO ENSURE THAT CABLES DO NOT ENCIRCLE THE PT'S NECK. SPECIAL ATTENTION IS NEEDED IN THE CASE OF CHILDREN." AS ADD'L MITIGATION, EMBLA DESIGNED THE SYS INTER-COMPONENT CABLES WITH TAMPER PROOF SCREW-IN CONNECTORS WHICH ARE TO BE SECURED BY THE END USER DURING INSTALLATION. IT COULD NOT BE DETERMINED BY THE CUSTOMER EVENT REPORT, OR BY FURTHER QUESTIONING, HOW THE CABLE BECAME DISCONNECTED, OR IF IT HAD BEEN PROPERLY SECURED PRIOR TO THE SLEEP STUDY IN QUESTION. ADVISED HEALTH CARE FACILITY OF THE WARNINGS AND CAUTIONARY STATEMENTS WITHIN THE INSTRUCTIONS FOR USE FOR THE EMBLA S7000 DEVICE WHEN WORKING WITH PEDIATRIC PTS AND REQUESTED FURTHER INFO ON THE EVENT. HEALTH CARE FACILITY WAS UNABLE TO PROVIDE ANY FURTHER DETAILS AND THE DEVICE WAS NOT RETURNED. DETERMINATION OF ABNORMAL USE BASED ON INCIDENT REPORT FROM HEALTH CARE FACILITY. (B)(4).