MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-15 for APOLLOBLUE 0007567-0015 manufactured by Lap Laser Gmbh.
[108807100]
A service engineer in the (b)(6) cancer treatment centre, (b)(6), went to unplug the power supply unit (psu) of the medical device apolloblue and the entire casing of the psu came away in his hand, exposing potentially live parts inside. This represents a health and safety hazard which might result in electrical shock. The psu is of type fw7660m/24 of the company friwo geratebau (b)(4). Used batch is 47130. There has been no harm or serious deterioration of persons.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681134-2018-04171 |
| MDR Report Key | 7514835 |
| Date Received | 2018-05-15 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-02-13 |
| Date Mfgr Received | 2018-02-20 |
| Device Manufacturer Date | 2018-05-12 |
| Date Added to Maude | 2018-05-15 |
| 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 |
| Reporter Occupation | HOSPITAL SERVICE TECHNICIAN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. HANS-PETER WERNER |
| Manufacturer Street | ZEPPELINSTRASSE 23 |
| Manufacturer City | LUNEBURG, 21337 |
| Manufacturer Country | GM |
| Manufacturer Postal | 21337 |
| Manufacturer G1 | LAP LASER GMBH |
| Manufacturer Street | ZEPPELINSTRASSE 23 |
| Manufacturer City | LUNEBURG, 21337 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 21337 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | APOLLOBLUE |
| Generic Name | LASER FOR PATIENT ALIGNMENT |
| Product Code | IWE |
| Date Received | 2018-05-15 |
| Returned To Mfg | 2018-03-06 |
| Model Number | 0007567-0015 |
| Operator | HOSPITAL SERVICE TECHNICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LAP LASER GMBH |
| Manufacturer Address | ZEPPELINSTRASSE 23 LUNEBURG, 21337 GM 21337 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-15 |