FDA Adverse Event
Malfunction
Summary report: N
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
MDR report key: 2930957
·
Received January 28, 2013
Report
- Report Number
- 9616091-2013-00128
- Event Type
- Malfunction
- Date Received
- January 28, 2013
- Report Date
- January 26, 2013
- Manufacturer
- RESPIRONICS INC
- Product Code
- BTI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL MANUFACTURER NARRATIVE: MDR REPORT 9616091-2013-00128 WAS INADVERTENTLY SUBMITTED UNDER MFR # 9616091. THE CORRECT MFR # FOR THIS REPORT IS 1531186.
Additional Manufacturer Narrative · 1
(B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES UNIT WILL NOT COME ON. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37082 | PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES | 868.6250 | BTI | RESPIRONICS INC | IRC1710 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |