MAUDE Adverse Event Report: MIPM MAMMENDORFER INSTITUT GMBH PROBE FOR CPMS; MONITOR, PRESSURE, INTRACOMPARTMENT

Catalog Number 530.412

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2015

Event Type  malfunction  

Event Description

It was reported that the probe device had an error message ¿ probe malfunction with nine uses remaining.According to the report, the event occurred when the surgeon was checking a patient¿s pressure.It was further reported that the surgeon did not use the device when he noticed the error message.There were no delays in the surgical procedure as a spare device was available for use.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

The manufacturer city was inadvertently documented as depuy synthes power tools.(b)(4).

• Brand Name: PROBE FOR CPMS
• Type of Device: MONITOR, PRESSURE, INTRACOMPARTMENT
• Manufacturer (Section D): MIPM MAMMENDORFER INSTITUT GMBH; oskar-von-miller str. 6; mammendorf ; GM
• Manufacturer (Section G): MIPM MAMMENDORFER INSTITUT GMBH; oskar-von-miller str. 6; mammendorf ; GM
• Manufacturer Contact: n/i n/i ; für physik und medizin gmbh; oskar-von-miller strasse 6; 82291 mammendorf, PA N/I ; GM N/I ; 6107195000
• MDR Report Key: 4772883
• MDR Text Key: 5786281
• Report Number: 2520274-2015-13493
• Device Sequence Number: 1
• Product Code: LXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK031555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.412
• Device Lot Number: US-21-1825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1