FDA Adverse Event
Other
Summary report: N
PNEUPAC PARAPAC PLUS
MDR report key: 19775396
·
Received July 17, 2024
Report
- Report Number
- MW5157365
- Event Type
- Other
- Date Received
- July 17, 2024
- Report Date
- July 15, 2024
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- BTL
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- 501
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
(B)(6) IS REPORTING A DELAY IN PM TURNAROUND TIME FOR SMITHS MEDICAL PM, INC. (B)(6) SENT ONE PARAPAC PLUS TO THE MANUFACTURER SMITHS MEDICAL PM, INC ON APRIL 3, 2024 FOR AN ANNUAL MAY PM. THE UNIT HAS NOT BEEN RETURNED BACK TO (B)(6) AS OF JULY 15, 2024, AND THE MANUFACTURER STATES THE PM HAS NOT BEEN COMPLETED DUE TO A SERVICE BACKLOG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2220980 | PNEUPAC PARAPAC PLUS | VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) | BTL | SMITHS MEDICAL ASD, INC. | PARAPAC PLUS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |