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

Model Number	N65-1
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the unit's liquid crystal display(lcd) display was incomplete and there was a missing segment.The customer reported that it provided readings in actual measurements.The lacked display was the 10 digit part of pulse reading.It was indicated that there was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample was evaluated.The device failed to meet specification as it was received or made available for evaluation.The customer reported the complaint mode that the unit's light emitting diode (lcd)) display:l.A visual inspection of the returned part was conducted and no anomalies were observed.The unit was attached to the failure investigation test bed device for analysis.The unit was powered up.The unit powered up normally and passed post.During set up when scrolling through the set-up menus, it was observed that there was a missing segment on one digit on the display.The cause of the observed condition was determined to be j8 connector on the user interface pcb.To fix the fault, the display flex cable was disconnected from the j8 connector on the user interface pcb and then properly reseated.The fi test bed device with the customer returned pcb installed was then operated successfully.No errors and no unexpected alarms were observed during the run in period.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.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; michael collins road; galway
• MDR Report Key: 7929499
• Report Number: 8020893-2018-00487
• Device Sequence Number: 16720707
• Product Code: DQA
• UDI-Device Identifier: 10884521096738
• UDI-Public: 10884521096738
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2015
• Device Model Number: N65-1
• Device Catalogue Number: N65-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1