Brand Name | BIPAP A30-S |
Type of Device | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE |
Manufacturer (Section D) |
RESPIRONICS |
1001 murry ridge lane |
murrysville PA 15668 |
|
Manufacturer (Section G) |
RESPIRONICS |
1001 murry ridge lane |
|
murrysville PA 15668 |
|
Manufacturer Contact |
adam
price
|
312 alvin drive |
new kensington, PA 15068
|
7243349303
|
|
MDR Report Key | 6503420 |
MDR Text Key | 73126558 |
Report Number | 2518422-2017-01000 |
Device Sequence Number | 1 |
Product Code |
MNT
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K113053 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial,Followup |
Report Date |
04/05/2017 |
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 |
Lay User/Patient
|
Device Model Number | 1078223 |
Device Catalogue Number | 1078223 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/21/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/05/2017 |
Initial Date FDA Received | 04/19/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/09/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/05/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
|
|
|