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

Model Number PM1000N

Device Problems Failure of Device to Self-Test (2937); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the unit had an error failed post test and also stated failed speaker test.There was no patient involvement.

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.

• Brand Name: NELLCOR
• Type of Device: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 10013714
• MDR Text Key: 189565465
• Report Number: 8020893-2020-00061
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10884521182530
• UDI-Public: 10884521182530
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM1000N
• Device Catalogue Number: PM1000N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2015
• 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