FDA Adverse Event
Injury
Summary report: N
ONESTEP CPR COMPLETE ZOLL MEDICAL CORPORATION
MDR report key: 19468325
·
Received June 4, 2024
Report
- Report Number
- MW5155738
- Event Type
- Injury
- Date Received
- June 4, 2024
- Date of Event
- May 26, 2024
- Report Date
- May 30, 2024
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- 501
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT SUSTAINED A WOUND ON LEFT SIDE OF CHEST FROM PADS SPARKING DURING DEFIBRILLATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1151152 | ONESTEP CPR COMPLETE ZOLL MEDICAL CORPORATION | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | MKJ | ZOLL MEDICAL CORPORATION | R2018-01 REV. M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Other |