MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND NELLCOR; OXIMETER

Model Number PM1000N

Device Problem Device Alarm System (1012)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/19/2021

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 use, the patient with tracheostomy cannula decannulated while sleeping.It was the ventilator that alarmed and alerted the healthcare team.The reported spo2 monitoring device did nothing when the patient desaturated with a reading of 52%.

• Brand Name: NELLCOR
• Type of Device: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 11821310
• MDR Text Key: 250800913
• Report Number: 8020893-2021-00064
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10884521182530
• UDI-Public: 10884521182530
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM1000N
• Device Catalogue Number: PM1000N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2021
• 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): Other