MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOHELP

Device Problems No Audible Alarm (1019); Improper Alarm (2951)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) provides product investigation, analysis and resolution for the device described in this report.A maquet service technician could not reproduce the problem.The device was returned to the "repair center" for a thorough investigation.A supplemental medwatch will be submitted when additional info becomes available.Reference exemption #(b)(4).This medwatch is related to medwatch report # 8010762-2014-00219 and (b)(4).

• Brand Name: MAQUET CARDIOHELP
• Type of Device: CARDIOHELP
• 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
• MDR Report Key: 3883046
• MDR Text Key: 4425284
• Report Number: 8010762-2014-00220
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Type of Report: Initial

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?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1