MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOPULMONARY AG; HL 20 4 -PUMPS CONSOLE BASE

Model Number 70104.3262

Device Problem Failure to Run on Battery (1466)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2013

Event Type  malfunction  

Event Description

It was reported by a maquet field service technician that during preventive maintenance, the pump on the hl20 console would not run when the system was on battery power.Ref.: # (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 field service technician adjusted the relay switch, verified proper operation and tested to factory specifications.Testing was successful and the unit was returned to service.

• Brand Name: MAQUET CARDIOPULMONARY AG
• Type of Device: HL 20 4 -PUMPS 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: 3698177
• MDR Text Key: 4262741
• Report Number: 8010762-2014-00010
• Device Sequence Number: 1
• Product Code: DTQ
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/10/2014,12/12/2013

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: 70104.3262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/12/2013
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2013
• Initial Date Manufacturer Received: 12/12/2013
• Initial Date FDA Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2009
• 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