• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP E.CAM; GAMMA CAMERA

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP E.CAM; GAMMA CAMERA Back to Search Results
Model Number 4380221
Device Problems Mechanical Problem (1384); Use of Device Problem (1670)
Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946)
Event Date 02/19/2015
Event Type  Injury  
Event Description
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.
 
Manufacturer Narrative
(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).
 
Manufacturer Narrative
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
E.CAM
Type of Device
GAMMA CAMERA
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP
2501 north barrington rd.
hoffman estates IL 60192
Manufacturer Contact
laura meyer
8473046022
MDR Report Key4586387
MDR Text Key5448941
Report Number1423253-2015-00002
Device Sequence Number1
Product Code IYX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
E142006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative,company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number4380221
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/18/2015
Initial Date FDA Received03/06/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received05/20/2015
06/26/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/1997
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-