MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE; HCU30 100-120 V

Model Number 70103.4371

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A maquet service technician evaluated the device and determined that half of the freon had leaked out.The source of the leak could not be determined so the compressor, dryer, freon valve and switch and all associated tubing were replaced.The unit was operated for two weeks with a recheck of the ice block and freon level.Both were satisfactory.Functional and safety checks were performed to factory specifications.The device was returned to service.

Event Description

It was reported that the device would only form half an ice block and then the entire tank would freeze over.No patient involvement.Issue was identified prior to treatment.Reference: (b)(4).

• Brand Name: MAQUET HCU30 DEVICE
• Type of Device: HCU30 100-120 V
• 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 drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 4016860
• MDR Text Key: 19452429
• Report Number: 8010762-2014-00281
• 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: 07/31/2014,07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70103.4371
• Device Catalogue Number: MCP00704629
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/01/2014
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2014
• Date Manufacturer Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2007
• 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