FDA.reportPublic FDA data

MAUDE MDR 7561819

MDR report key
7561819
Report number
1929691-2018-00003
Event key
0
Event type
3
Date of event
2018-05-01
Date received
2018-06-01
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
MS. GINA BENNETT
Address
4600 VINE STREET LINCOLN NE 68503 US
Phone
402-402-4027
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STANLEY HEALTHCAREM200STANLEY SECURITY SOLUTIONSKMIM200M200Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-0101. R

Event Narratives#

N

Patient 1

(B)(4) -- "ERRATIC OPERATION" (DAMAGED MALE PAD CONNECTOR AND DAMAGED FEMALE MONITOR JACK) (SHIP DATE 7/28/2016). CUSTOMER REPORT NUMBER -- MW5077241. CAPA NUMBER -- (B)(4). PAD 1 JACK RETENTION TABS ARE BROKEN - THIS WILL KEEP THE PAD PLUG FROM STAYING IN PLACE, BUT AS WE HAVE SHOWN IN THE PAST THIS FAILURE MODE DOES NOT PREVENT THE MONITOR FROM ALARMING IF IT HAS BEEN ARMED PROPERLY. SEE RED ARROWS BELOW INDICATING AREA OF DAMAGE. THE PLUG ON THE 73030 CHAIR PAD IS DAMAGED - THIS IS CAUSING THE UNIT TO ALARM WHEN THE PAD IS FIRST PRESSED RATHER THAN WHEN PRESSURE IS RELEASED. THIS IS THE FAILURE MODE THAT IS BEING DESCRIBED AS "REVERSE POLARITY" BELOW. THE SWITCH SETTINGS ARE SET SO THAT THE UNIT IS NON-LATCHING - THIS IS A VIABLE OPTION BUT IT WILL TURN THE ALARM OFF IF PRESSURE IS REAPPLIED TO THE PAD, RATHER THAN HAVING TO GO TO THE MONITOR TO RESET I THE ALARM. THE NURSE CALL CORD THAT WAS SENT IN WITH THE UNITS IS IN GOOD WORKING ORDER. DAMAGE TO THE JACKS IS CONSIDERED TO BE THE ROOT CAUSE OF THIS FAILURE. AS DISCUSSED VIA PHONE IT COULD BE BENEFICIAL TO YOUR ORGANIZATION AND OURS IF JR AND I WERE TO VISIT YOUR FACILITY TO INVESTIGATE HOW THIS PRODUCT IS BEING USED IN THE MERCY ENVIRONMENT. IT IS OUR SUSPICION THAT THIS SORT OF DAMAGE IS CAUSED DURING TERMINAL CLEAN OPERATIONS AT THE END USER-SITE OR BY END-USERS NOT COMPRESSING THE TAB ON THE MALE TELEPHONE JACK WHEN REMOVING IT FROM THE PORT. STANLEY HEALTHCARE HAS DESIGNED INTO THE M200 A STRAIN RELIEF FEATURE FOR THIS REASON. PAGE 27 OF THE USER MANUAL DOES PROVIDE DIRECTION ON HOW TO UTILIZE THIS FEATURE. IT IS EVIDENT THAT YOUR STAFF TESTED THIS UNIT, AS THE FAILURE WAS CAUGHT PRIOR TO INSTALLATION. THE TESTING OPERATION DEFINED ON PAGE 20 IS OUR SURETY THAT THE UNIT IS READY FOR USE, AND UNIT LET YOU KNOW IT WAS NOT. AS DESCRIBED IN (B)(4) LETTER (MAY 15, 2018, RMA (B)(4)) WE DO HAVE DESIGN IMPROVEMENTS IN PROCESS THAT WILL MAKE THE JACK MORE ROBUST AS WELL AS PROVIDE ADDITIONAL VISUAL AID TOOLS TO THE UNIT. THE MOVING OF LABELS TO THE FRONT OF THE UNIT IS INTENDED TO BETTER DIRECT THE END-USER TO THE CORRECT PORT, THUS, FOR EXAMPLE, REDUCING THE CHANCE OF PHONO JACKS BEING INSERTED INTO THE TELEPHONE JACK PORT. [MW50077241.PDF].

D

Patient 1

CHAIR ALARM MALFUNCTIONED. WHEN PATIENT STOOD UP, THE CHAIR ALARM "SET" AS IF PATIENT WAS SITTING DOWN INSTEAD OF SOUNDING OFF. WHEN THE PATIENT SAT BACK DOWN THE CHAIR ALARM THEN SOUNDED OFF INSTEAD THE ALARM. THE PRODUCT HAS ALREADY BEEN RETURNED TO THE MANUFACTURER.