MAUDE Adverse Event Report: GE HEALTHCARE GE COROMETRICS 259CX FETAL MONITOR; TOCOTRANSDUCER

Catalog Number FQGE8859CX

Device Problems Circuit Failure (1089); Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

The complaint device was returned for evaluation.Incoming visual inspection did not identify any anomalies.Technical visual inspection did not identify any anomalies.Device evaluation found a bad spo2 pcb, confirming the issue.The spo2 pcb was replaced.The circuit boards were inspected.The case was checked for damage.The device was tested on a simulator.The display, ecg, ibp, nibp, on/off power, recorder, spo2, and temp test all passed.The root cause was determined to be the aged masimo spo2 pcb.This was not related to the previous repair.This type of event will continue to be monitored.

Event Description

Reportedly, post repair, the device had spo2 issues.There was no patient involvement.No additional information is available.

• Brand Name: GE COROMETRICS 259CX FETAL MONITOR
• Type of Device: TOCOTRANSDUCER
• Manufacturer (Section D): GE HEALTHCARE; 8880 gorman rd; laurel MD 20723
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: jenna vargas ; 212 avenida fabricante; san clemente, CA 92672
• MDR Report Key: 9211416
• MDR Text Key: 166133072
• Report Number: 3007409280-2019-00042
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FQGE8859CX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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