FDA Adverse Event Other Summary report: N

PASSPORT

MDR report key: 454501 · Received April 4, 2003

Report

Report Number
454501
Event Type
Other
Date Received
April 4, 2003
Date of Event
September 27, 2002
Report Date
October 11, 2002
Manufacturer
DATASCOPE CORP.
Product Code
DXW
Report Source
User Facility report
Reporter Location
TN, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PASSPORT PHYSIOLOGIC [BLOOD PRESSURE] MONITOR DXW DATASCOPE CORP. PASSPORT 2 *

Patients

Seq Age Sex Outcome Treatment
1 83 YR Other