MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOPULMONARY AG; HL 20 CONSOLE BASE

Model Number 701035075

Device Problems Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 02/18/2014

Event Type  malfunction  

Event Description

It was reported that intermittent "rev rel" (reverse relay) error message appeared at power up and the right side motor ran rough at low rpm.No patient involvement.Internal reference: (b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.A maquet service technician investigated the device and replaced the interconnect pcb, right side motor and power button lens.A complete preventative maintenance with full calibration and functional testing to factory specifications was successfully performed.A supplemental medwatch will be submitted if additional information becomes available.

• Brand Name: MAQUET CARDIOPULMONARY AG
• Type of Device: HL 20 CONSOLE BASE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond dr; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3829407
• MDR Text Key: 4398415
• Report Number: 8010762-2014-00116
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/18/2014,02/18/2014

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: Health Professional
• Device Model Number: 701035075
• Device Catalogue Number: MCP00703323
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/18/2014
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2014
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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