ED PULSECHECK 5.4

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-20 for ED PULSECHECK 5.4 manufactured by Picis Clinical Solutions, Inc..

Event Text Entries

[29222607] Picis clinical solutions received an enhancement request on (b)(6)-2015: (b)(6) hospital (och) - can the access to document weight in pounds be completely removed from the er record? Och is reporting 3 near misses within the last week with infant weights being recorded in pounds instead of kilos. Ensuring that weight is recorded correctly is a patient safety issue as weight is used to calculate medication dosages" further investigation determined that there were no reported patient incidents related to the enhancement request. The ed pulsecheck product currently has two template fields for the documentation of a patient's weight, a field to document in pounds and a field to document weight in kilograms. The clinician must document in the field that corresponds to the units in which the weight was measured. The near misses reported were related to a clinician documenting inaccurate information into a clearly labeled template field within ed pulsecheck. Picis clinical solutions, inc. Is planning to release the next version of the ed pulsecheck product in the fourth quarter of 2015. This version of ed pulsecheck (v5. 6) will include an enhancement option to only display the kg field for weight data entry. This enhancement may minimize the risk of a data entry error, although the enhancement does not prevent the risk of data entry error. The ed pulsecheck product did not cause or contribute to an adverse event and did not malfunction. The ed pulsecheck product operated as intended, however based upon the fda's mdr guidance related to user error picis clinical solutions, inc. Is submitting this medical device report to the fda.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005244943-2015-00003
MDR Report Key5162171
Date Received2015-10-20
Date of Report2015-09-22
Date Mfgr Received2015-09-22
Date Added to Maude2015-10-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. KERRY ARMSTRONG
Manufacturer Street100 QUANNAPOWITT PARKWAY SUITE 405
Manufacturer CityWAKEFIELD MA 01880
Manufacturer CountryUS
Manufacturer Postal01880
Manufacturer Phone7815573000
Manufacturer G1PICIS CLINICAL SOLUTIONS, INC.
Manufacturer Street100 QUANNAPOWITT PARKWAY SUITE 405
Manufacturer CityWAKEFIELD MA 01880
Manufacturer CountryUS
Manufacturer Postal Code01880
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameED PULSECHECK
Generic NameSOFTWARE, TRANSMISSION AND STORAGE
Product CodeNSX
Date Received2015-10-20
Model Number5.4
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPICIS CLINICAL SOLUTIONS, INC.
Manufacturer Address100 QUANNAPOWITT PARKWAY SUITE 405 WAKEFIELD MA 01880 US 01880


Patients

Patient NumberTreatmentOutcomeDate
10 2015-10-20

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