FDA Adverse Event
Malfunction
Summary report: N
AED PLUS
MDR report key: 2182120
·
Received June 23, 2011
Report
- Report Number
- 1220908-2011-01743
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Report Date
- June 1, 2011
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K011541
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL; HOWEVER, THE CUSTOMER RETURNED THE (B)(4) FOR REVIEW. EVAL OF THE (B)(4) FOUND THAT THE PRESENTED HEART RHYTHM FAILED TO MEET THE REQUIREMENTS FOR DEFIBRILLATION AND THE DEVICE APPROPRIATELY RETURNED A "NO SHOCK ADVISED" PROMPT. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ANALYZING THE HEART RHYTHM OF A PT THE DEVICE RETURNED A "NO SHOCK ADVISED" DETERMINATION FOR WHAT APPEARED TO BE A SHOCKABLE RHYTHM. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AED PLUS | DEFIBRILLATOR | MKJ | ZOLL MEDICAL CORPORATION | AED PLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |