MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HL20 DEVICE

Model Number 70102.8580

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2014

Event Type  malfunction  

Event Description

It was reported that prior to use, the cardioplegia mode was not available on the hl20 device.(b)(4).

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device (b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.A maquet service technician evaluated the device and identified a defective console control module and replaced it.The cardioplegia mode returned on the device.A supplemental medwatch will be submitted if additional information becomes available.

• Brand Name: MAQUET HL20 DEVICE
• Type of Device: HL20
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strabe 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond dr.; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3915267
• MDR Text Key: 4670402
• Report Number: 8010762-2014-00212
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/27/2014,04/30/2014

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: 70102.8580
• Device Catalogue Number: 70102.8580
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/27/2014
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/30/2014
• Initial Date FDA Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1