MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES CA/USA OLM INTRACRANIAL PRESSURE MONITORING KIT; N/A

Catalog Number 1104B

Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Event Description

For the second case, the 1104-b was also zeroing in a normal way.After connecting to a camino model cam01 to monitor a certain patient, the indicator originally showed the normal numbers (around 10 to 11).After a period of monitoring (around 5 to 6 hours), the indicator dropped to negative figures (around -1).Five hours later, the indicator went up to around 5 and 6.The customer connected the 1104-b to another camino to test and the icp indicators shown were similar.Additional information has been requested.Linked to mfg.Report number: 2023988-2017-00040.

Manufacturer Narrative

Investigation completed 07/19/2017.Complaint history, model 110-4xxx, from (b)(6) 2015 through (b)(6) 2017 reviewed; there were seven other complaints that issued with complaint code (b)(4), and one of them was confirmed.The number of confirmed reports (01) divided by the number of units sold model 110-4xxx, ((b)(4)), (b)(6) 2015 through (b)(6) 2017 and multiplied by 100 results in a failure rate percentage (b)(4).The customer¿s complaint ¿for the second case, the 1104-b is also zeroing in a normal way.After connecting to a camino model cam01 to monitor a certain patient, the indicator originally showed the normal numbers (around 10 to 11).After a period of monitoring (around 5 to 6 hours), the indicator dropped to negative figures (around -1).Five hours later, the indicator went up to around 5 and 6¿ could not be confirmed as the customer did not return the device for evaluation.

• Brand Name: OLM INTRACRANIAL PRESSURE MONITORING KIT
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer (Section G): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6697763
• MDR Text Key: 79818641
• Report Number: 2023988-2017-00041
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K102875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1104B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1