MAUDE Adverse Event Report: MCKESSON CORP HEMODYNAMIC PC/MONITOR; HEMODYNAMIC SYSTEM, DIAGNOSTIC, NON-IMPLANTABLE

Model Number HCH 200 HXP

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2015

Event Type  malfunction  

Event Description

Two outpatients were at the facility for scheduled aortograms.Because of an unanticipated breakdown of the patient monitoring equipment in the cardiac catheterization laboratory, both of the scheduled procedures were cancelled and the outpatients had to be rescheduled for the next day for their procedure.Staffing and workload adjustments were the immediate actions that needed to be taken because of this event.Contributing factor: technology issue.Biomedical engineering and it were able to replace an external control unit / module allowing the recording system to communicate and record vitals and import into the patient record.The repair took approximately four hours.

• Brand Name: HEMODYNAMIC PC/MONITOR
• Type of Device: HEMODYNAMIC SYSTEM, DIAGNOSTIC, NON-IMPLANTABLE
• Manufacturer (Section D): MCKESSON CORP; 5995 windward pkwy.; alpharetta GA 30005
• MDR Report Key: 4951925
• MDR Text Key: 6190521
• Report Number: 4951925
• Device Sequence Number: 1
• Product Code: DQK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HCH 200 HXP
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2015
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2015
• Patient Sequence Number: 1