MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA 3100-IQ; INTERVENTIONAL FLUOROSCOPIC X-RAY

Lot Number 602239LAB4

Device Problems Loss of Power (1475); Ambient Temperature Problem (2878)

Patient Problem Death (1802)

Event Date 02/27/2013

Event Type  Death  

Event Description

On june 29, 2015, ge healthcare received a notification that a patient death occurred on (b)(6) 2013.The patient was undergoing a coronary angiography examination and the system shut down during the examination due to a high ambient temperature in the technical room.The customer did not inform ge healthcare of this event when it occurred.

Manufacturer Narrative

Patient weight currently not available.Initial reporter email not provided.Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

Ge healthcare's investigation has been completed.This site is serviced by an in-house third party service technician who found that the technical room was extremely warm due to the hospital air conditioner wall mount thermostat failure and informed hospital staff that air conditioning had to be repaired.It was confirmed that the hospital air-conditioning failure caused a sudden increase of temperature in the technical room resulting in a chiller thermal protection relay activation which inhibits all x-ray imaging functionality after a 3 min warning because the x-ray tube cannot be cooled anymore.This is the normal behavior of the vascular system.The operator manual clearly highlights system environmental specifications (including temperature/humidity).The user should install and maintain air conditioning to avoid temperature rises beyond the specifications.In the event of high room temperature resulting in the chiller relay activation, the innova system displays an alarm on the in-room monitor alerting the user that x-ray functionality will be disabled in 3 min, giving sufficient time to secure the patient.The system was corrected on february 27, 2013 by in-house third party service technician by cooling the technical room and resetting the chiller high pressure cut out relay.The customer was also informed to repair the air conditioning, and has been informed several times in the past to correctly maintain the technical room to ensure proper system functioning.No system malfunction has been identified, the system worked as intended and per specifications.No further action is required.

Manufacturer Narrative

Ge healthcare's investigation has been completed.This site is serviced by an an in-house third party service technician who found that the technical room was extremely warm due to the hospital air conditioner wall mount thermostat failure and informed hospital staff that air conditioning had to be repaired.It was confirmed that the hospital air-conditioning failure caused a sudden increase of temperature in the technical room resulting in a chiller thermal protection relay activation which inhibits all x-ray imaging functionality after a 3 min warning because the x-ray tube cannot be cooled anymore.This is the normal behavior of the vascular system.The operator manual clearly highlights system environmental specifications (including temperature/humidity).The user should install and maintain air conditioning to avoid temperature rises beyond the specifications.In the event of high room temperature resulting in the chiller relay activation, the innova system displays an alarm on the in-room monitor alerting the user that x-ray functionality will be disabled in 3 min, giving sufficient time to secure the patient.The system was corrected on (b)(6) 2013 by in-house third party service technician by cooling the technical room and resetting the chiller high pressure cut out relay.The customer was also informed to repair the air conditioning, and has been informed several times in the past to correctly maintain the technical room to ensure proper system functioning.No system malfunction has been identified, the system worked as intended and per specifications.No further action is required.

• Brand Name: INNOVA 3100-IQ
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• Manufacturer (Section G): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc, 78530 ; FR 78530
• Manufacturer Contact: tammy lee ; 3000 n grandview blvd, w450; waukesha, WI 53188 ; 2625482169
• MDR Report Key: 4949536
• MDR Text Key: 15242081
• Report Number: 9611343-2015-00007
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K092004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 602239LAB4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2003
• 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
• Patient Outcome(s): Death
• Patient Age: 70 YR