FDA Adverse Event
Malfunction
Summary report: N
PNEUPAC PARAPAC MEDIC MODEL
MDR report key: 16864671
·
Received May 3, 2023
Report
- Report Number
- 3012307300-2023-05010
- Event Type
- Malfunction
- Date Received
- May 3, 2023
- Report Date
- January 9, 2024
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL, LTD.
- Product Code
- BTL
- PMA / PMN Number
- K020899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF EVENT AND D4: UDI NUMBER ARE UNKNOWN.NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN REQUIRED.
Additional Manufacturer Narrative · 0
OTHER, OTHER TEXT: ON REVIEW, THIS FILE WAS FOUND TO BE A DUPLICATE AND ALL INFORMATION WILL BE SUBMITTED ON 3012307300-2023-04270. PLEASE DISREGARD ALL FILES ASSOCIATED WITH 3012307300-2023-05010.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE DEVICE WAS NOT VENTILATING. NO INJURY REPORTED. REPORTED ITEM NUMBER IS 510A1954NUS WITH REPORTED LOT NUMBER 1105272; WHICH IS PART OF PARAPAC KIT WITH ITEM NUMBER 120003. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 488164 | PNEUPAC PARAPAC MEDIC MODEL | VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) | BTL | SMITHS MEDICAL INTERNATIONAL, LTD. | 1105272 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |