MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-03-06 for E.CAM 4380221 manufactured by Siemens Medical Solutions Usa, Inc. Mi Group.
[5448941]
Customer narrative: "customer was installing medium energy collimator on head one, head 2 aligned, head on cart not aligned, customer pushed collimator on halfway, realized collimator not on track, attempted to pull collimator back off, collimator fell on right hand. " mfr narrative: the operator of the e. Cam gamma camera nuclear medicine system was in the process of changing the collimators (accessory) prior to use of the e. Cam system. There was a misalignment, which did not allow the proper change of the collimator; however, the customer continued to perform the collimator change resulting in the collimator falling and impacting the right hand of the operator. A misaligned collimator exchange should not be attempted. Following the labeling instructions for collimator change would reduce the potential for injury or damage to the system. In this case, the customer chose to attempt to change the collimator despite the misalignment issue, which resulted in the fall of the collimator and injury. The operator injury consisted of a broken finger and cut that required an undisclosed number of stitches. There was no pt involved in the event and the incident only involved the operator of the device.
Patient Sequence No: 1, Text Type: D, B5
[39115608]
(b)(6). During a review of files we determined that the patient identifier submitted with the original form fda 3500a was incorrect. This supplement corrects the patient identifier (icd).
Patient Sequence No: 1, Text Type: N, H10
[39232420]
This supplement is being submitted to correct "date of event". During follow-ups on this complaint, we became aware on 06/22/2015 that the reported date of event (02/18/2015) was incorrect. The correct date of event ((b)(6) 2015) is being submitted via this supplement report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423253-2015-00002 |
| MDR Report Key | 4586387 |
| Report Source | 05,07 |
| Date Received | 2015-03-06 |
| Date of Report | 2015-02-18 |
| Date of Event | 2015-02-19 |
| Date Mfgr Received | 2015-02-18 |
| Device Manufacturer Date | 1997-12-01 |
| Date Added to Maude | 2015-03-11 |
| 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 | LAURA MEYER |
| Manufacturer Phone | 8473046022 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E.CAM |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2015-03-06 |
| Model Number | 4380221 |
| 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. MI GROUP |
| Manufacturer Address | 2501 NORTH BARRINGTON RD. HOFFMAN ESTATES IL 60192 US 60192 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-06 |