MAUDE Adverse Event Report: ST PAUL SPECTRO2 10 PULSE OXIMETER

Model Number WW1000EN

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported the device was getting an error code of e25.No patient injury was reported.

Manufacturer Narrative

No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed due to the fact that no samples, pictures or videos were received to perform a thorough investigation.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record (dhr) review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: SPECTRO2 10 PULSE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2304 county road 3000 n; minneapolis, MN 55442
• MDR Report Key: 15320374
• MDR Text Key: 302805040
• Report Number: 3012307300-2022-16718
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418000016
• UDI-Public: 30843418000016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083787
• 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: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WW1000EN
• Device Catalogue Number: WW1000EN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1