MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. TRUSAT; OXIMETER, EAR

Device Problems Use of Device Problem (1670); Compatibility Problem (2960)

Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685)

Event Date 06/11/2021

Event Type  Injury  

Manufacturer Narrative

Udi not required.Legal manufacturer: (b)(4).The customer did not provide a serial number for the device.The information is not available because the customer did not provide a serial number for the device.Ge healthcare's investigation is ongoing at this time.A follow-up report will be submitted when the investigation is completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that a patient sustained a burn injury from the trusat pulse oximeter while undergoing a mri scan.Per the user manual, the trusat is not intended for use in a mri environment.

Manufacturer Narrative

Investigation findings: ge healthcare (gehc) was unable to obtain any additional information with regards to the trusat involved, its evaluation and the spo2 accessory in use.In addition, the customer declined to provide any further details pertaining to the patient's current status.A picture of the reported injury was provided for gehc evaluation.Also, a picture of the spo2 sensor that was in use was subsequently obtained.Per evaluation by gehc engineering, it was determined that the spo2 sensor in use at the time was a generic sensor, and not manufactured by gehc.The actual manufacturer is unknown.In addition to the warning that the trusat "is not intended for use in a magnetic resonance imaging (mr) environment", the trusat user's guide also contains a warning to use "only sensors and cables specified for use with this monitor." gehc has not identified any other recent complaint alleging a similar issue in relation to the trusat.Gehc's investigation concluded that there was no indication of a device malfunction.

• Brand Name: TRUSAT
• Type of Device: OXIMETER, EAR
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer (Section G): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer Contact: kristof soos ; 8200 w tower ave; milwaukee, WI 53223
• MDR Report Key: 15192133
• MDR Text Key: 297524373
• Report Number: 3008729547-2022-00004
• Device Sequence Number: 1
• Product Code: DPZ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K040831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 09/22/2022
• 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
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Sex: Female
• Patient Weight: 50 KG