MAUDE Adverse Event Report: MCKESSON PROVIDER TECHNOLOGIES MCKESSON; CHARTING SYSTEM CPU

Model Number HCH220DW7

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Loss of Power (1475)

Patient Problem No Information (3190)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

Intra-procedural failure of hemodynamic ,ecg and vital signs monitoring capability.While performing a intra-vascular procedure the mckesson hemodynamics monitoring system shut down and froze upon return to functioning.This is an ongoing issue with multiple different incidents of failure.Manufacture has been working to resolve without successful resolution.

• Brand Name: MCKESSON
• Type of Device: CHARTING SYSTEM CPU
• Manufacturer (Section D): MCKESSON PROVIDER TECHNOLOGIES; 5995 windward parkway; alpharetta GA 30005
• MDR Report Key: 4438777
• MDR Text Key: 5310791
• Report Number: MW5040284
• Device Sequence Number: 2
• Product Code: DQK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HCH220DW7
• Other Device ID Number: 76752232
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 57