MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE; HCU30 200V-240V

Model Number 70102.8718

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2014

Event Type  Injury  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal mfr of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.Maquet cardiopulmonary ag provides product failure investigation, analysis and resolution for the device described in this report.A maquet field service tech evaluated the device and found that a 12 amp fuse had tripped.The fuse was re-set and the unit was returned to service.A supplemental medwatch will be submitted as soon as add'l info becomes available.Ref exemption code - e2008006s01.

Event Description

It was reported that the hcu30 device shut off during use and could not be restarted.The unit was exchanged for another unit.No pt injury.Ref: (b)(4).

• Brand Name: MAQUET HCU30 DEVICE
• Type of Device: HCU30 200V-240V
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond dr.; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 14755685
• MDR Text Key: 294482344
• Report Number: 8010762-2014-00229
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2014,05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70102.8718
• Device Catalogue Number: 70102.8718
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/19/2014
• Device Age: 66 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2014
• Date Manufacturer Received: 05/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2008
• 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
• Patient Outcome(s): Required Intervention