MAUDE Adverse Event Report: ORIDION MEDICAL NELLCOR; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number N85

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: one device handheld monitor was received for evaluation.The battery had a date code of (b)(6) 2016, which is past the two-year limit where it would normally be replaced at factory service.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the unit was not really used on a patient.There was a code blue on a patient, they were going to use this unit on the patient to check spo2 and co2.But when the unit was turned on, it was red and did not give any kind of readings at all.

• Brand Name: NELLCOR
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• Manufacturer (Section G): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8095641
• MDR Text Key: 128278966
• Report Number: 8044004-2018-00012
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10884521172043
• UDI-Public: 10884521172043
• Combination Product (y/n): N
• Reporter Country Code: VT
• PMA/PMN Number: K915494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N85
• Device Catalogue Number: N85
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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