PNEUPAC PARAPAC PLUS
Report
- Report Number
- 3012307300-2023-06258
- Event Type
- Malfunction
- Date Received
- June 15, 2023
- Report Date
- June 21, 2024
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL, LTD.
- Product Code
- BTL
- UDI-DI
- 35019315107263
- PMA / PMN Number
- K123957
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION IS PROVIDED IN FUNCTIONAL TESTING DID NOT CONFIRM THE CUSTOMER?S COMPLAINT. THE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE PRODUCT IS BEYOND A YEAR FROM MANUFACTURE DATE AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DHR REVIEW WAS NOT PERFORMED. THE SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FOR ALL ENQUIRIES OR FOLLOW-UP QUESTIONS RELATED TO THE RECORD, DO NOT USE [email protected] LOCATED IN SECTIONS G.1., PLEASE DIRECT THOSE TO THE FOLLOWING: [email protected]. D.4. FULL UDI NUMBER: (01)10610586040818(11)142619(21)2017419.
OTHER, OTHER TEXT: B3: DATE OF EVENT IS 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.
IT WAS REPORTED THAT THE PRESSURE GAUGE WAS NOT WORKING. PATIENT INVOLVEMENT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 946023 | PNEUPAC PARAPAC PLUS | VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) | BTL | SMITHS MEDICAL INTERNATIONAL, LTD. | P310NUS | 35019315107263 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |