MAUDE Adverse Event Report: NEW MERVUE INDUSTRIAL PARK NELLCOR

Model Number FE201GE-SK

Device Problem High Readings (2459)

Patient Problems Anoxia (1711); Coma (2417)

Event Date 08/03/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a procedure for toe amputation, the unit gave a high readings.The customer reported that the pulse oximeter was not displaying an accurate peripheral oxygen saturation, it reads 100% despite this measure the patient for some period of time was hypoxic and as a result has anoxic brain injury.The patient required cardiac pulmonary resuscitation and had anoxic brain injury and is currently in coma.

• Brand Name: NELLCOR
• Manufacturer (Section D): NEW MERVUE INDUSTRIAL PARK; michael collins road; galway
• Manufacturer (Section G): NEW MERVUE INDUSTRIAL PARK; michael collins road; galway
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 7958370
• MDR Text Key: 123486775
• Report Number: 8020893-2018-00496
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FE201GE-SK
• Device Catalogue Number: FE201GE-SK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2018
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 74