MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-02 for CP1000 manufactured by Agfa-gevaert Healthcare Gmbh.
[47650496]
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Patient Sequence No: 1, Text Type: N, H10
[47650497]
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.
Patient Sequence No: 1, Text Type: D, B5
[50743028]
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.
Patient Sequence No: 1, Text Type: N, H10
[50743029]
The serial number provided was incorrect. This supplement report is being submitted to provide the correct serial number and the root cause.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613152-2016-00001 |
| MDR Report Key | 5695689 |
| Date Received | 2016-06-02 |
| Date of Report | 2016-07-29 |
| Date of Event | 2016-05-05 |
| Date Mfgr Received | 2016-05-11 |
| Date Added to Maude | 2016-06-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. CASSANDRA MCGOWAN |
| Manufacturer Street | 10 SOUTH ACADEMY STREET |
| Manufacturer City | GREENVILLE SC 29601 |
| Manufacturer Country | US |
| Manufacturer Postal | 29601 |
| Manufacturer Phone | 8644211984 |
| Manufacturer G1 | AGFA-GEVAERT HEALTHCARE GMBH |
| Manufacturer Street | MAX PLANCK STRASSE 1 |
| Manufacturer City | PEISSENBERG BAYERN, GERMANY D82380 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D82380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CP1000 |
| Generic Name | CP1000 |
| Product Code | IXW |
| Date Received | 2016-06-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGFA-GEVAERT HEALTHCARE GMBH |
| Manufacturer Address | MAX PLANCK STRASSE 1 PEISSENBERG BAYERN, GERMANY D82380 GM D82380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-02 |