MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOPULMONARY AG; ROTAFLOW CONSOLE

Device Problems Low Battery (2584); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

Ref# imp (b)(4).

Manufacturer Narrative

(b)(4).Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.A maquet field service technician investigated the device and replaced the batteries.Complete functional testing was successfully performed.A supplemental medwatch will be submitted if additional information becomes available.Reference exemption # (b)(4).

• Brand Name: MAQUET CARDIOPULMONARY AG
• Type of Device: ROTAFLOW CONSOLE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; hechinger strasse 38; hirrlingen 7643 7; GM 76437
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3773593
• MDR Text Key: 4435116
• Report Number: 8010762-2014-00177
• 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: 04/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1