MAUDE Adverse Event Report: CARDIOQUIP LLC CARDIOQUIP; MCH-1000(M)

Model Number MCH-1000(M)

Device Problem Intermittent Loss of Power (4016)

Patient Problem No Information (3190)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

A service technician inspected the unit and was not able to replicate the issue, which caused the unit to go into "standby" mode.The unit was tested for functionality and passed the manufacturers' inspection.

Event Description

Customer reports that the unit goes to back to "standby" mode after being put into run mode during a case.The customer attempted to run the unit multiple times afterward, each time running only for one minute or less before going back into standby mode.

• Brand Name: CARDIOQUIP
• Type of Device: MCH-1000(M)
• Manufacturer (Section D): CARDIOQUIP LLC; 3827 old college rd; bryan TX 77801
• Manufacturer (Section G): CARDIOQUIP; 3827 old college rd; bryan TX 77801
• Manufacturer Contact: melanie harry ; 3827 old college rd; bryan, TX 77801 ; 9796910202
• MDR Report Key: 8676019
• MDR Text Key: 190684111
• Report Number: 3007899424-2019-00002
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MCH-1000(M)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1