MAUDE Adverse Event Report: SANMINA-SCI SYSTEMS (M) SDN BHD N65P HANDHELD PULSE OXIMETER X1

Model Number N65P

Device Problem Improper Device Output (2953)

Patient Problem No Patient Involvement (2645)

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported failure of "unit display was missing segments" was verified.This is a known issue and has been isolated to the user interface printed circuit board (ui pcb) and action has been taken under remedial action efforts.Complaint trends will continue to be monitored.

Event Description

The reporter stated the n65 pulse oximeter display was missing segments.There was no patient involved.

• Brand Name: N65P HANDHELD PULSE OXIMETER X1
• Type of Device: PULSE OXIMETER
• Manufacturer (Section D): SANMINA-SCI SYSTEMS (M) SDN BHD; 202, lorong perusahaan maju 9; bukit tengah industrial park; perai penang 13600 ; MY 13600
• Manufacturer (Section G): PENANG; 202, lorong perusahaan maju 9; perai penang ; MY
• Manufacturer Contact: thom mc namara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5627498
• MDR Text Key: 44803406
• Report Number: 2936999-2016-00340
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N65P
• Device Catalogue Number: N65P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2267-2015
• Patient Sequence Number: 1