MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC NEUROMONITOR BASIC KIT; DEVICE INTRACRANIAL PRESSURE MONITORING

Catalog Number 82-6631

Device Problem Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

We are still waiting for more information regarding this complaint.(b)(6) 2015, equipment not working.Recurrent problem with repeated efforts to try and rectify the issue.On this occasion the equipment failed overnight leading to an incomplete data set on one patient.A second patient who was planned for the same procedure today has been cancelled (on the day cancellation) as the ward manager cannot now reply on the equipment.|message sent to paediatric national benchmarking group to ascertain if problems encountered elsewhere.Codman informed.No injury to patient or health care professional.Equipment removed from use.Next theatre case requiring equipment has been cancelled (risk assessment done) medical physics informed and equipment currently with them.Message to paediatric national benchmarking group to ascertain if problems encountered elsewhere, codman informed.It seems that sheffield teaching hospitals have had similar problems but have not reported this.

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.Unclear if device will be returned.

Manufacturer Narrative

It has been communicated that the device is not available for evaluation.Without the device it is not possible for codman to conduct a proper investigation.Since a lot number has been provided, a review of the manufacturing records has been conducted, and they revealed that the device conformed to all manufacturing and quality testing/inspection specifications prior to being released to stock.If at some point the device is returned for evaluation this complaint will be re-opened and investigated.Based on this evaluation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.Device not available.

• Brand Name: NEUROMONITOR BASIC KIT
• Type of Device: DEVICE INTRACRANIAL PRESSURE MONITORING
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4545630
• MDR Text Key: 5522099
• Report Number: 1226348-2015-10120
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK914479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 82-6631
• Device Lot Number: CRDBCJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1