MAUDE Adverse Event Report: MCKESSON PROVIDER TECHNOLOGIES MCKESSON; MCKESSON HEMODYNAMICS SYSTEM/CPU MONITORING

Model Number HCH100DWZ

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: MCKESSON HEMODYNAMICS SYSTEM/CPU MONITORING
• 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: 1
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HCH100DWZ
• Device Catalogue Number: 50253755
• Other Device ID Number: 76655702/FFV7GZ1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2015
• 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