MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES, LTD PRE-AMP CABLE, MPM-1. CONNECTS MONITOR TO CATHET; N/A

Catalog Number PAC1

Device Problem Connection Problem (2900)

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

Event Date 11/04/2015

Event Type  malfunction  

Event Description

It was reported that the cable has a bad contact.Additional information has been requested.

• Brand Name: PRE-AMP CABLE, MPM-1. CONNECTS MONITOR TO CATHET
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES, LTD; newbury road; newbury road; andover hampshire ; UK
• Manufacturer (Section G): INTEGRA NEUROSCIENCES, LTD; newbury road; andover hampshire ; UK
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5248268
• MDR Text Key: 32225202
• Report Number: 8010219-2015-00050
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K962928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: PAC1
• Device Lot Number: MCE1415101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1