MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. DIRECTLINK ICP MODULE; DEVICE, INTRACRANIAL PRESSURE MONITORING

Model Number	82-6828
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
As reported by the rep, after a directlink gave incorrect readings following post -op insertion of the microsensor, then en-route to the icu, the icp read "???".After unsuccessfully attempting to re-synchronized the direct link, the cable was changed there were no reports of patient harm.
Additional Manufacturer Narrative
Additional information: the device was returned for evaluation.No issue was identified with the product.A review of manufacturing records could not be performed, as no lot or serial number is available on the cable.The reported issue could not be performed.The device functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: DIRECTLINK ICP MODULE
• Common Device Name: DEVICE, INTRACRANIAL PRESSURE MONITORING
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle, CH240 0; SZ CH2400
• MDR Report Key: 7710054
• Report Number: 1226348-2018-10502
• Device Sequence Number: 921043
• Product Code: GWM
• UDI-Device Identifier: 10886704078661
• UDI-Public: (01)10886704078661
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 82-6828
• Device Catalogue Number: 82-6828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1