MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-15 for STREAMLAB manufactured by Siemens Healthcare Diagnostics Inc..
[117299002]
Siemens was notified by the original equipment manufacturer for streamlab that a pacemaker safety label (implanted cardiac device) may be missing from certain streamlab systems. The potentially impacted streamlab modules are the core unit / lynx with input output module (iom) and refrigerated storage module. Siemens was further informed that the minimum safety distance from devices emitting a magnetic field should be increased to 200 millimeters (7. 87 inches). Siemens has issued an urgent medical device correction titled aptio? Automation streamlab? Automation some modules missing pacemaker warning labels ((b)(4)) and an urgent field safety notification titled aptio? Automation streamlab? Automation some modules missing pacemaker warning labels ((b)(4)) to all affected customers.
Patient Sequence No: 1, Text Type: N, H10
[117299003]
Siemens was notified by the original equipment manufacturer (oem) for sreamlab that an ongoing investigation has determined that a pacemaker safety label (implanted cardiac device) may be missing from certain streamlab systems. Siemens was further informed that the minimum safety distance from devices emitting a magnetic field should be increased to 200 millimeters (7. 87 inches). There are no known reports of adverse health consequences due to the missing pacemaker safety label or the increase of the minimum safety distance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2018-00449 |
| MDR Report Key | 7786204 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-15 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-07-27 |
| Date Mfgr Received | 2018-07-27 |
| Date Added to Maude | 2018-08-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARL AEBIG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243102 |
| Manufacturer G1 | INPECO S.P.A |
| Manufacturer Street | VIA GIVOLETTO 15 ITALY REGISTRATION #: 30055092 |
| Manufacturer City | 10040 VAL DELLA TORRE (TORINO), |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2517506-08/15/2018-007-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STREAMLAB |
| Generic Name | STREAMLAB |
| Product Code | LXG |
| Date Received | 2018-08-15 |
| Model Number | STREAMLAB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-15 |