MAUDE Adverse Event Report: VISICU, INC - DUP ECARECOMPANION; ECAD BP MEDIUM/LG

Model Number 453564551731

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bruise/Contusion (1754)

Event Type  Injury  

Event Description

Customer reported that the bp cuff caused bruising on a patient after use.

Manufacturer Narrative

Philips h2h q&r has completed the investigation for the report of a bp cuff causing bruising after use.The device was not returned for investigation so testing on this specific device was not possible.However, the vendor (a&d) previously investigated bp cuffs of the same product family that caused bruising after use.A&d conducted a maximum inflation level test since over-inflation is the most common cause of arm bruising during/after use.The returned devices stopped inflation at 299 mmhg and met the safety design requirement of 300 mmhg.The inflation level of the bp measurement depends on the patient¿s hypertensive condition.The bp cuff will inflate higher if the patient is more hypertensive and lower if the patient is less hypertensive.Higher pressure generated by the device will result in a tighter obstruction, whereas lower pressure will result in a looser obstruction.Thus, a tighter obstruction may lead to a higher change of skin bruising and feeling discomfort or a resulting bruise is possible for hypertension patients.The patient who reported this incident¿s hypertensive condition is unknown.This complaint is confirmed for bruising but not confirmed for a device malfunction as the device was not returned for investigation.H2h q&r will continue to monitor for trends.

• Brand Name: ECARECOMPANION
• Type of Device: ECAD BP MEDIUM/LG
• Manufacturer (Section D): VISICU, INC - DUP; 217 e redwood st ste 1900; baltimore MD 21202
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: sarah aultowski ; 217 e redwood st ste 1900; baltimore, MD 21202
• MDR Report Key: 6760954
• MDR Text Key: 81627878
• Report Number: 1125873-2017-00006
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 453564551731
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other