MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN ICP EXPRESS; DEVICE, INTRACRANIAL PRESSURE MONITORING

Model Number	82-6634
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
As reported by the affiliate, an icp express would not reach the proper reading after being zeroed.After being zeroed, the monitor would not climb to 20.The highest the monitor would reach is 6, and would climb very slowly.Another was used to complete the procedure.There were no reports of delay or patient harm.
Additional Manufacturer Narrative
The device was returned and evaluated.The customer's reported issue could not be confirmed.The unit appeared to have been opened by the customer (damaged internal frame and battery not connected) and would not turn on.Damaged digital and analog boards, and damaged internal frame were all replaced.The unit was retested and passed all tests.A review of manufacturing records from the supplier was performed and it was found that the device conformed to specification when released to stock.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN ICP EXPRESS
• Common Device Name: DEVICE, INTRACRANIAL PRESSURE MONITORING
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham 02767
• MDR Report Key: 7746696
• Report Number: 1226348-2018-10559
• Device Sequence Number: 1861030
• Product Code: GWM
• UDI-Device Identifier: 10886704042341
• UDI-Public: (01)10886704042341
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

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: No Information
• Device Model Number: 82-6634
• Device Catalogue Number: 82-6634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1