MAUDE Adverse Event Report: PHILLIPS BP MONITOR

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).

• Brand Name: BP MONITOR
• Type of Device: BP MONITOR
• Manufacturer (Section D): PHILLIPS; roselle IL 60172
• MDR Report Key: 5522275
• MDR Text Key: 41143295
• Report Number: MW5061231
• Device Sequence Number: 1
• Product Code: DXN
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M3001 A
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 78