MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG ROTAFLOW; ROTAFLOW ENGLISH/US ICU

Device Problems Low Battery (2584); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Type  Death  

Event Description

Reference importer report number (b)(4).

Manufacturer Narrative

(b)(4).Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.A supplemental medwatch will be submitted if additional information becomes available.(b)(4).

• Brand Name: ROTAFLOW
• Type of Device: ROTAFLOW ENGLISH/US ICU
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strabe 31; rastatt 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3569928
• MDR Text Key: 4053118
• Report Number: 8010762-2014-00001
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 12/07/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1