FDA Adverse Event
Malfunction
Summary report: N
VENTILATOR PARAPAC MEDIC MODEL 200D
MDR report key: 9973264
·
Received April 17, 2020
Report
- Report Number
- 3012307300-2020-03092
- Event Type
- Malfunction
- Date Received
- April 17, 2020
- Report Date
- June 29, 2020
- Product Code
- BTL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
OTHER, OTHER TEXT: ONE VENTILATOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE FOUND IT TO BE IN GOOD PHYSICAL CONDITION. DEVICE UNDERWENT FUNCTIONAL TESTING BY DELIVERING TO TEST LUNG, MANOMETER GAUGE NOTED TO NOT MOVE. UPON INSPECTION, NOTICED THAT THE TUBING THAT GOES TO THE MANOMETER WAS NOT CONNECTED. THE REPORTED CUSTOMER COMPLAINT HAS BEEN CONFIRMED WITH A PROBLEM SOURCE OF SERVICE AND REPAIR.
Description of Event or Problem · 0
RO 1055879: GAGES NOT WORKING. REPEAT REPAIR RO#1041261 RMA#245409.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT THE GAUGES ARE NOT WORKING. NO ADVERSE EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 437053 | VENTILATOR PARAPAC MEDIC MODEL 200D | BTL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |