FDA Adverse Event
Malfunction
Summary report: N
ESSENCE COMPRESSOR
MDR report key: 4122154
·
Received September 18, 2014
Report
- Report Number
- 9681154-2014-00026
- Event Type
- Malfunction
- Date Received
- September 18, 2014
- Date of Event
- August 20, 2014
- Report Date
- August 1, 2014
- Manufacturer
- RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.
- Product Code
- CAF
- PMA / PMN Number
- K042655
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION CONCLUDED THAT THE CORD APPEARED TO BE DAMAGED BY A SHARP TOOL AND THAT CAUSED EXPOSED WIRING.
Description of Event or Problem · 1
THE MANUFACTURER RECEIVED INFO ON (B)(4) 2014 ALLEGING AN ESSENCE COMPRESSOR HAD A BROKEN POWER CORD OR SHORT. THERE WAS NO ALLEGATION OF EXPOSED WIRING, THERE WAS NO HARM OR INJURY AT THE TIME OF REPORTING. THE UNIT WAS RETURNED TO (B)(4) ON THE (B)(4) 2014, AT WHICH TIME POWER CORD WAS OBSERVED TO HAVE EXPOSED WIRES. DEVICE RECEIVED BY (B)(4) AND EVALUATED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 579266 | ESSENCE COMPRESSOR | COMPRESSOR, AIR, PORTABLE | CAF | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. | 1099966 | 130305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |