MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. ICP EXPRESS PRESSURE MONITOR; SPINAL FLUID PRESSURE MONITOR, ELECTRICAL

Catalog Number 82-6635

Device Problem False Reading From Device Non-Compliance (1228)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It has been reported that the device will not be returned for evaluation.A serial number has been provided.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the ous affiliate, an icp displays inaccurate readings.There were no reports of delay or patient harm.

Manufacturer Narrative

Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no issues when the device was released.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar complaints.At present, we consider this complaint to be closed.

• Brand Name: ICP EXPRESS PRESSURE MONITOR
• Type of Device: SPINAL FLUID PRESSURE MONITOR, ELECTRICAL
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7378447
• MDR Text Key: 103792365
• Report Number: 1226348-2018-10240
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K945585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-6635
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention