PASSPORT PASSPORT 2 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-04-04 for PASSPORT PASSPORT 2 * manufactured by Datascope Corp..

Event Text Entries

[19494436] Title: automatic blood pressure cuff. The pt was admitted to the emergency dept with chest pain and a blood pressure of 240/100. The pt was placed on an automatic blood pressure machine. The pt was in the ed from 0100-0500 and then discharged. They returned to the ed at 1350. They were tearful and stated that the blood pressure cuff had injured their left arm. They did have a large black area on their upper arm. The physician had not given an order for a time interval for the blood pressure to be taken. The nurse set the time interval based on "their routine. " this pt was hypertensive; therefore, the inflation pressure that was required was higher than in a normotensive pt. This particular blood pressure machine was checked by the biomedical engineering dept and no problems were found with the machine. The facility has not contacted the manufacturer. It is not known if the labeling instructions contain info regarding use with specific populations. The facility does not have any written guidelines as to when to use or not use the automatic blood pressure machines. These machines are part of the new employee competency-based education program which involves training sessions on setting the controls and general use of this particular machine. It is not known if this machine has caused any injury in the past, but the facility has had 2 other pt complaints of bruising from automatic blood pressure machines. Since this is the third occurrence of pt injury with automatic blood pressure machines, the site is considering ways to eliminate this problem. The nursing standards team is addressing the issue of how long to leave a pt on the automatic blood pressure machine. To date, this team has not been able to find any documented standards. Other factors that might prevent future occurences: one option would be manual blood pressure or setting frequency less often.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number454501
MDR Report Key454501
Date Received2003-04-04
Date of Report2002-10-11
Date of Event2002-09-27
Report Date2002-10-11
Date Reported to FDA2002-10-11
Date Added to Maude2003-04-21
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePASSPORT
Generic NamePHYSIOLOGIC [BLOOD PRESSURE] MONITOR
Product CodeDXW
Date Received2003-04-04
Model NumberPASSPORT 2
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Device Age2 YR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key443503
ManufacturerDATASCOPE CORP.
Manufacturer Address800 MACARTHUR BLVD. MAHWAH NJ 07430 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2003-04-04

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