MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BCI® SPECTRO2¿ 30 PULSE OXIMETER REMOTE ALARM CABLE

Catalog Number WW1067NC

Device Problems Melted (1385); Overheating of Device (1437); Charging Problem (2892); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a bci® spectro2¿ 30 pulse oximeter remote alarm cable became hot and melted.The nurse involved reported that the call system did not work properly, the oximeter was not fully charged, and the cable began to smell like plastic.No injury was reported.

• Brand Name: BCI® SPECTRO2¿ 30 PULSE OXIMETER REMOTE ALARM CABLE
• 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 rd.; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7169598
• MDR Text Key: 96593334
• Report Number: 3012307300-2017-02630
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 08/24/2021
• Device Catalogue Number: WW1067NC
• Device Lot Number: FE1132
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1