MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. BCI® SPECTRO2¿ 10 PULSE OXIMETER

Model Number 1000

Device Problem Material Fragmentation (1261)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

One smiths medical bci® spectro2¿ 10 pulse oximeter was returned for analysis in good condition.Inspection was performed, parts were swapped, was powered on/off, and a sp02 test was completed.Upon receipt of monitor, a rattling sound come from inside.The monitor was opened and found the ram battery with its bracket dislodged from the main board.The cause of the loose parts was found due to impact.Which caused the soldered bracket to come apart from the main board; damaging the red flashing alarm led near the top of the main board.Based on the evidence, the root cause was from user interface.

Event Description

Information was received indicating a loose piece was noted in a smiths medical bci® spectro2¿ 10 pulse oximeter.There were no reported adverse effects.

• Brand Name: BCI® SPECTRO2¿ 10 PULSE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL PM, INC.; n7w22025 johnson dr ; waukesha WI 53186
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 7651744
• MDR Text Key: 112846351
• Report Number: 3012307300-2018-02389
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418000191
• UDI-Public: 30843418000191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1000
• Device Catalogue Number: WW1030EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1