MAUDE Adverse Event Report: NULL BCI; OXIMETER

Model Number WW1090

Device Problems Deformation Due to Compressive Stress (2889); Charging Problem (2892)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the battery on a smiths medical oximeter cannot be charged.Strong heating and deformation of the battery casing.No patient involvement.

• Brand Name: BCI
• Type of Device: OXIMETER
• Manufacturer (Section G): NULL
• MDR Report Key: 11144585
• MDR Text Key: 225992388
• Report Number: 3012307300-2021-00240
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: WW1090
• Device Catalogue Number: WW1090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1