ONESTEP PEDIATRIC
Report
- Report Number
- 1218058-2024-00111
- Event Type
- Malfunction
- Date Received
- December 16, 2024
- Report Date
- November 25, 2024
- Manufacturer
- BIO-DETEK INCORPORATED
- Product Code
- MKJ
- PMA / PMN Number
- P160022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
JUSTIFICATION FOR NO UDI: THIS DEVICE HAS A UDI; SOME INFORMATION WAS NOT PROVIDED AND IS UNKNOWN; THEREFORE, A COMPLETE UDI CANNOT BE PROVIDED. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
THE DEVICE WAS NOT RETURNED TO ZOLL MEDICAL CORPORATION. INSTEAD, COMMUNICATION WITH THE CUSTOMER IDENTIFIED THE RED TABS WERE NOT UTILIZED AS ILLUSTRATED ON THE PACKAGING WHEN THE ELECTRODE PADS WERE REMOVED FROM THE STYRENE LINER. ELECTRODE PADS NEED TO BE REMOVED FROM PACKAGING IN THE PROPER SEQUENCE PER THE INSTRUCTIONS FOR USE AND THE PACKAGING ILLUSTRATIONS. THE CUSTOMER REPORTED THAT THE TEAM WAS ABLE TO APPLY PADS TO THE PATIENT AND DEFIBRILLATE. THE CUSTOMER HAS BEEN MADE AWARE OF THE APPROPRIATE METHOD TO OPEN THE ELECTRODE PADS PACKAGING. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A 21-MONTH-OLD MALE PATIENT, THE PADS WERE DAMAGED DURING REMOVAL OF PACKAGING. COMPLAINANT INDICATED THAT THE CLINICIAN WAS ABLE TO PLACE PADS BACK TOGETHER AND PROPERLY REMOVE IT FROM THE PACKAGING TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2356074 | ONESTEP PEDIATRIC | ELECTRODES | MKJ | BIO-DETEK INCORPORATED | 8900-000219-01 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 MO | Male |