MAUDE Adverse Event Report: RAYNHAM ICP EXPRESS, 220 VOLT, JAPAN; ICP EXPRESS - MONITOR

Catalog Number 826637

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 11/08/2023

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This is linked to mfg report number 3013886523-2023-00431.A physician reported a microsensor (id 826631) was placed on (b)(6), 2023.It was connected to the bedside monitor philipps/ intellivue mx800 in intensive care unit (icu).The philipps monitor showed a margin of error of plus2mmhg compared with icp express (id 826637).It was used with cable (id 826636, lot number 104007).On (b)(6), 2023, the icp sensor was extracted since the patient became stable.The sensor was not replaced.According to the information provided the sensor failure was discovered when the physician used icp express and philipps/intellivue mx800 at the same time, and noticed the difference in displayed value.It is unknown if the patient experienced any signs and symptoms due to sensor issue.No surgery delay was reported.

• Brand Name: ICP EXPRESS, 220 VOLT, JAPAN
• Type of Device: ICP EXPRESS - MONITOR
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18339903
• MDR Text Key: 330667478
• Report Number: 3014334038-2023-00190
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 826637
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2023
• 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
• Patient Age: 81 YR
• Patient Sex: Male