MAUDE Adverse Event Report: AGFA-GEVAERT HEALTHCARE GMBH CP1000

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Information (3190)

Event Date 05/05/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

An event of a fire involving a cp1000 unit occurred at the site on (b)(6) 2016.The dealer reported to agfa on may 11, 2016, that the cp1000 unit was involved in a fire.The unit was installed 1.5 years ago and the last service activity was on april 6, 2015.The unit was working as intended before the fire occurred.The affected device is sold and maintained by a third party dealer.Agfa will provide a replacement unit to the customer.The root cause has not yet been identified.Potential causes can be: overheating or short circuit of components can cause melt down and smoke development or fire.Leaking of chemicals on electrical components can cause smoke development or fire to the device.An external source (heat/flame) can cause smoke development or fire to the device.Several safety precautions have been listed in the "reference manual" of the device to prevent the above mentioned conditions.Additionally, agfa requires installation of a gfi (ground fault interrupter) 30 ma-type for both people and fire protection in case of a potential incident.There has been no reported harm to patient or user during this event.Pictures have been provided to show visual property damage.

Manufacturer Narrative

Serial # was corrected from (b)(4).During the investigation by agfa, between 06/20 - 07/04, the root cause was identified.The analysis of the remainders showed the cp1000 was subjected to the fire but not the source of the fire.There have been no reports of harm to users or patients during these events.

Event Description

The serial number provided was incorrect.This supplement report is being submitted to provide the correct serial number and the root cause.

• Brand Name: CP1000
• Type of Device: CP1000
• Manufacturer (Section D): AGFA-GEVAERT HEALTHCARE GMBH; max planck strasse 1; peissenberg bayern, germany D8238 0; GM D82380
• Manufacturer (Section G): AGFA-GEVAERT HEALTHCARE GMBH; max planck strasse 1; peissenberg bayern, germany D8238 0; GM D82380
• Manufacturer Contact: cassandra mcgowan ; 10 south academy street; greenville, SC 29601 ; 8644211984
• MDR Report Key: 5695689
• MDR Text Key: 47650496
• Report Number: 9613152-2016-00001
• Device Sequence Number: 1
• Product Code: IXW
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K981280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2016

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 06/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2016
• 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: N
• Patient Sequence Number: 1