MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. CAPNOSTAT MODULE; MONITOR, PHYSIOLOGICAL, PATIENT

Device Problems Thermal Decomposition of Device (1071); Circuit Failure (1089); Hole In Material (1293); Melted (1385); Overheating of Device (1437); Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation of the issue is on-going at this time.A follow-up report will be submitted when the investigation is completed.

Event Description

It was reported the device was not starting up.Visual inspection found the device to have a hole burned through the casing and the casing was partially melted.There was no patient involvement.

Manufacturer Narrative

Ge healthcare's investigation of the reported issue is as follows: the named device was returned from the customer site to ge healthcare (gehc) for further evaluation.Gehc engineering evaluation confirmed the module housing had a hole burned through it and was partially melted.Internal inspection identified a pcb board was damaged where the burn occurred; engineering was not able to identify the exact location where the overheating started due to the damage and there are no components mounted in this region of the printed circuit board assembly that would cause the overheating condition.A broken connector was found indicating the device may have been dropped.A definitive root cause of the failure could not be determined; potential causes could be a hardware failure, co2 sensor failure, contamination, or customer misuse (mishandling).No adverse trend was identified; this issue will be tracked and trended.

• Brand Name: CAPNOSTAT MODULE
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 8200 w tower ave; milwaukee, WI
• Manufacturer Contact: kristof soos ; 8200 w. tower ave; milwaukee, WI
• MDR Report Key: 6915143
• MDR Text Key: 89478604
• Report Number: 2124823-2017-00002
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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