MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC SPECTRO 2 MONITOR; OXIMETER

Model Number WW1030EN

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation results: one spectro 2 monitor was received in used condition.A visual inspection of the device revealed dirt and dried fluid in the battery compartment.The monitor was opened up and it was determined that the customer had dropped the monitor because the coin battery had come out of the bracket and was loose internally.The red led light did not displat as a result during power up.The customer's reported problem was replicated.The main board was replaced as a result.The device passed all functional test after this measure was taken.

Event Description

It was reported that the spectro 2 monitor gave an unspecified error.No patient injury or complications were reported in relation to this event.

• Brand Name: SPECTRO 2 MONITOR
• Type of Device: OXIMETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8652040
• MDR Text Key: 146494580
• Report Number: 3012307300-2019-03658
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418000191
• UDI-Public: 30843418000191
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: WW1030EN
• Device Catalogue Number: WW1030EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Date Manufacturer Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1