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

Model Number 70103.4371

Device Problems Device Displays Incorrect Message (2591); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2014

Event Type  No Answer Provided  

Event Description

It was reported that while in use on a pt, the device could not deliver temperatures below 33c.After restarting the device, multiple alarms occurred and the right side of the screen went blank.The unit was swapped for another.No pt injury reported.Reference: (b)(4).Ref.Mfr # 8010762-2014-00218.

• Brand Name: MAQUET HCU30 DEVICE
• Type of Device: HCU30 100V-120V
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 3883006
• MDR Text Key: 4424755
• Report Number: 3008355164-2014-00106
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/29/2014,04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70103.4371
• Device Catalogue Number: 70103.4371
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/05/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 106