MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) PRE-AMP CABLE, MPM-1. CONNECTS MONITOR TO CATHET; N/A

Catalog Number PAC1

Device Problem Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

Integra has completed their internal investigation on 19nov2015.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: although the cable passed functional inspection to it0343 displaying icp and temperature values within specifications, the cable failed visual inspection; the zero/span adjustment potentiometer was glued in place - white residue found on the casing, and the cover for the potentiometer was missing, indicating an attempt to modify the cable.The cable could not be repaired.Dhr review was completed for pac-1 cable and it was deemed satisfactory.There were no non-conformance reports raised during the manufacturing process for this cable.Date of manufacture: aug-2014.The analysis of the complaint investigations and root cause reports has concluded this complaint is the first identified complaint for the reported failure associated with the pac-1 cable that was modified by the user.No trend has been identified.Conclusion: the cause of the cable not working was due to modifications attempted to the pac-1 cable potentiometer by the user, resulting in missing potentiometer cover and white residue found on the casing.

Event Description

An out of box failure was reported.Additional information was received on 21aug2015 with the following: the device was not in contact with the patient.There was no patient injury.There was no increase in surgery time.

• Brand Name: PRE-AMP CABLE, MPM-1. CONNECTS MONITOR TO CATHET
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• 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: 5270951
• MDR Text Key: 32795536
• Report Number: 8010219-2015-00067
• 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: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• 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: 544143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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