FDA.reportPublic FDA data

MAUDE MDR 7495953

MDR report key
7495953
Report number
2020362-2018-00029
Event key
0
Event type
3
Date received
2018-05-08
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#

Contact
WILLIAM HINCY
Address
POSEY COMPANY 5635 PECK ROAD ARCADIA CA 91006 US
Phone
626-626-6264
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALARM SENSOR, BED SENSOR PAD 6MTHMONITOR, BED PATIENTPOSEY PRODUCTS LLCKMI830783077179T052Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-0801. R

Event Narratives#

N

Patient 1

PRODUCT IS SCHEDULED TO BE RETURNED BUT HAVE NOT BEEN RECEIVED IN BY MANUFACTURING AT THE TIME OF THIS REPORT. THEREFORE, THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE #(B)(4).. NO PRODUCT RETURNED AT THIS TIME.

D

Patient 1

CUSTOMER REPORTED THE SENSOR IS NOT ALWAYS SENDING A SIGNAL TO THE ALARM TO SOUND. A PATIENT FELL AND SUFFERED A SCRAPE ON HIS BACK. ADDITIONAL INFORMATION FROM THE CUSTOMER STATED THE SCRAPE WAS CLEANED AND COVERED WITH A BAND AID. NO OTHER TREATMENT WAS ADMINISTERED. THE DATE THE INCIDENT OCCURRED WAS NOT REPORTED.