FDA.reportPublic FDA data

MAUDE MDR 5980602

MDR report key
5980602
Report number
2518422-2016-03823
Event key
0
Event type
3
Date of event
2015-10-13
Date received
2016-09-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
600
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. ADAM PRICE
Address
312 ALVIN DRIVE NEW KENSINGTON PA 15068 US
Phone
724-724-7243
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALICE 5 SYSTEMELECTROENCEPHALOGRAPH/POLYSOMNOGRAPHY SYSTEMRESPIRONICS, INC.OLZC1068726C1068726R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-2701. S

Event Narratives#

D

Patient 1

THE MANUFACTURER RECEIVED INFORMATION FROM A LAW FIRM THAT A "RESPIRONICS PRODUCT ALICE 5 PSG POLYSOMNOGRAPHY MALFUNCTIONED AND CAUSED BURNING TO PLAINTIFF'S SKIN AND PERMANENT DISFIGUREMENT TO HIS FACE". THERE WAS NO OTHER INFORMATION REGARDING THE ALLEGED INJURY OR MEDICAL INTERVENTION REQUIRED. INFORMATION RECEIVED INDICATES THE PLAINTIFF'S ALLEGED EVENT MAY HAVE OCCURRED AT (B)(6) ON APPROXIMATELY (B)(6) 2015. THERE IS NO INDICATION THE MANUFACTURER WAS NOTIFIED OF THIS ALLEGED EVENT AT THE TIME. A SEARCH OF THE MANUFACTURER'S COMPLAINT SYSTEM YIELDED NO SIMILAR COMPLAINTS. THE ALICE 5 SYSTEM IS A POLYSOMNOGRAPHY SYSTEM THAT IS INTENDED TO RECORD, DISPLAY,AND PRINT PHYSIOLOGICAL INFORMATION FOR CLINICIANS OR PHYSICIANS. THESE PARAMETERS ARE PRESENTED GRAPHICALLY ON A COMPUTER SCREEN FOR DIAGNOSTIC REVIEW SIMILAR IN APPLICATION TO THE USE OF A TRADITIONAL PAPER-BASED POLYGRAPH RECORDER. THE DEVICE IS USED IN HOSPITALS, INSTITUTIONS, SLEEP CENTER OR CLINICS, OR OTHER TEST ENVIRONMENTS WHERE ADULT OR INFANT PATIENTS REQUIRE THE DOCUMENTATION OF VARIOUS SLEEP OR OTHER PHYSIOLOGICAL DISORDERS. THE ALICE 5 EQUIPMENT COLLECTS THE DATA FROM SENSORS PLACED ON A PATIENT AND DELIVERS THE DATA TO A COMPUTER RUNNING THE SLEEPWARE APPLICATION. THE ALICE SLEEPWARE APPLICATION IS A (B)(6) BASED SOFTWARE PROGRAM DESIGNED TO MONITOR, DISPLAY, PROCESS, AND DOWNLOAD POLYSOMNOGRAPHIC DATA RECORDED WITH THE ALICE 5 EQUIPMENT. THERE WAS NO SERIAL NUMBER OR MATERIAL NUMBER PROVIDED FOR THE ALICE 5 SYSTEM. A MATERIAL NUMBER IS BEING ASSIGNED FOR THIS REPORT, BUT MAY CHANGE IF A SERIAL NUMBER OR MATERIAL NUMBER ARE OBTAINED AND CONFIRMED. THE MANUFACTURER'S INVESTIGATION IS ON-GOING. REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION AND THE RETURN OF THE DEVICE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

N

Patient 1

THE MANUFACTURER RECEIVED INFORMATION THAT THE ALICE 5 POLYSOMNOGRAPHY DEVICE IS NOT IMPLICATED IN THE PATIENT'S ALLEGED INJURY. THE USER FACILITY CONFIRMED THAT THE DEVICE WAS NEVER TAKEN OUT OF SERVICE, HAS BEEN USED ON OTHER PATIENTS SINCE THE REPORTED EVENT, AND THERE HAVE BEEN NO ISSUES. CONFIRMATION OF THE SERIAL NUMBER WAS RECEIVED FROM THE USER FACILITY, THEREFORE THE MATERIAL NUMBER, CATALOG NUMBER, AND SERIAL NUMBERS HAVE BEEN UPDATED ACCORDINGLY ON THIS REPORT. NO FURTHER ACTION IS REQUIRED.