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 Tissue Damage (2104)

Event Type  Injury  

Event Description

A skin tear occurred while using the device, which required medical intervention and/or additional treatment.

• 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 HEALTHCARE (ALPHARETTA); one deerfield center; 13560 morris road ste 2100; alpharetta GA 30004
• Manufacturer Contact: sharon fishter ; 217 e redwood st ste 1900; baltimore, MD 21202
• MDR Report Key: 9728684
• MDR Text Key: 180760329
• Report Number: 1125873-2020-00002
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 00884838084452
• UDI-Public: (01)00884838084452
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 453564551731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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