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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILLIPS BP MONITOR

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PHILLIPS BP MONITOR Back to Search Results
Model Number M3001 A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Skin Discoloration (2074); Swelling (2091); Injury (2348)
Event Date 03/06/2016
Event Type  Injury  
Event Description
Pt post emergent cabg. As the staff removed the drapes upon surgery completion, they found that his rt arm was discolored and swollen. The blood pressure cuff was removed and indentations were noted. The limb was elevate and an ultrasound was done which was negative. It was suspected that the air in the cuff never fully released. The cuff was only used in the very beginning of the case, before the arterial line was placed. The pt's arms were padded and tucked to the side. Staff questioned if the tucking of the arm caused a kink in the bp cuff tubing. A phillips monitor was hooked up to the bp cuff and was used in the manual mode. There was no error message, alarm or anything from the phillips module indicating a problem. The pt had a wrist drop (radial nerve injury) and arm pain post-op. A ct of the head was negative. Occupational therapy was ordered. The pain and function improved somewhat over the hospitalization, but some neuro deficits were still present on discharge on (b)(6) 2016. Pt discharged on neurontin. The biomed department tested the philips monitor and could not replicate any problem. There was also no issue found with the welch allen trimline reusable blood pressure cuff. (adult).
 
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Brand NameBP MONITOR
Type of DeviceBP MONITOR
Manufacturer (Section D)
PHILLIPS
roselle IL 60172
MDR Report Key5522275
MDR Text Key41143295
Report NumberMW5061231
Device Sequence Number1
Product Code DXN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberM3001 A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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