Brand Name | 10 LEAD ECG TRUNK AAMI/IEC 2M |
Type of Device | ECG TRUNK CABLE |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
hewlett-packard str.2 |
boeblingen 71034 |
GM 71034 |
|
Manufacturer (Section G) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
|
andover MA 01810 |
|
Manufacturer Contact |
wendy
chadbourne
|
hewlett-packard str.2 |
boeblingen 71034
|
GM
71034
|
|
MDR Report Key | 5278429 |
MDR Text Key | 33621458 |
Report Number | 9610816-2015-00300 |
Device Sequence Number | 1 |
Product Code |
DSA
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K020531 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
11/24/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | M1663A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/24/2015
|
Initial Date FDA Received | 12/09/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 02/16/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|