MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-10-19 for ECAM 5989087 manufactured by Siemens Medical Solutions Usa, Inc..
[19663262]
We received a report regarding a pt injury (broken leg), that was sustained while the pt was on a hosp gurney and being scanned with the e. Cam gamma camera. According to the operator, the pt was placed on a hosp gurney beneath the detector. The detector collided with the hosp gurney and the pt sustained the broken leg injury.
Patient Sequence No: 1, Text Type: D, B5
[19750433]
The mfr's investigation has determined that the incident was due to user error as the operator initiated a home command and acknowledged that the gantry area was clear while the pt was actually beneath the detector. Method - logs from computer system analyzed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423253-2010-00003 |
| MDR Report Key | 1876020 |
| Report Source | 06 |
| Date Received | 2010-10-19 |
| Date of Report | 2010-09-15 |
| Date of Event | 2010-09-14 |
| Date Mfgr Received | 2010-09-14 |
| Device Manufacturer Date | 2002-09-01 |
| Date Added to Maude | 2010-10-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA EBIO, MGR |
| Manufacturer Street | 2501 NORTH BARRINGTON RD. |
| Manufacturer City | HOFFMAN ESTATES IL 60192 |
| Manufacturer Country | US |
| Manufacturer Postal | 60192 |
| Manufacturer Phone | 8652182534 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECAM |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2010-10-19 |
| Model Number | 5989087 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | HOFFMAN ESTATES IL 60192 US 60192 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-10-19 |