MAUDE Adverse Event Report: N/I PROBE FOR CPMS; MONITOR, PRESSURE, INTRACOMPARTMENT

Catalog Number 530.412

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 03/07/2014

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition could not be confirmed.An assignable root cause was not determined.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Correction: the manufacturer city was inadvertently documented as depuy synthes power tools.This product probe for cpms is not manufactured by depuy synthes and is manufactured by: mipm.All further investigation will be performed by mipm.

Event Description

It was reported from (b)(6) that during a compartmental pressure monitoring surgical procedure, it was discovered that the probe device displayed an ¿error code¿.According to the reporter, the procedure was being performed to determine if surgery was an option for chronic exertional compartment syndrome.There was a twenty five minute delay to the planned surgical procedure.An identical spare device was available for use.There was patient involvement reported.There were no reports of 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

Initial reporter¿s phone number: (b)(6).The manufacturer¿s information was unknown.Device manufacture date was unknown.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PROBE FOR CPMS
• Type of Device: MONITOR, PRESSURE, INTRACOMPARTMENT
• Manufacturer (Section D): N/I; n/i; n/i
• Manufacturer Contact: n/i n/i ; für physik und medizin gmbh; oskar-von-miller strasse 6; mammendorf, 82291, PA 19380-N/I ; GM 19380N/I ; 6107195000
• MDR Report Key: 3770831
• MDR Text Key: 12180830
• Report Number: 2520274-2014-10911
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• 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: 25-1585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1