FDA Adverse Event
Malfunction
Summary report: N
LEVEL 1 EQUATOR BLOWERS
MDR report key: 11859733
·
Received May 20, 2021
Report
- Report Number
- 3012307300-2021-04746
- Event Type
- Malfunction
- Date Received
- May 20, 2021
- Date of Event
- April 21, 2021
- Report Date
- December 29, 2021
- Manufacturer
- ST PAUL
- Product Code
- DWJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
ONE UNIT WAS RETURNED FOR INVESTIGATION. UPON PHYSICAL INSPECTION, IT WAS FOUND THAT THE COMPLAINED ISSUE COULD BE DUPLICATED. A MANUFACTURING DHR REVIEW WAS NOT PERFORMED BECAUSE THE RESULTS OF THE COMPLAINT INVESTIGATION DO NOT INDICATE A PROBLEM WITH THE MANUFACTURE OF THE DEVICE.
Additional Manufacturer Narrative · 1
CUSTOMER CONTACT PHONE NUMBER: (B)(6)
Description of Event or Problem · 1
KW 05-20-2021. IT WAS REPORTED THAT THE LEVEL 1 EQUATOR BLOWER EXHIBITED AN INTERNAL COMBUSTION AS SOON AS IT WAS TURNED ON. THERE WAS NO PATIENT INVOLVED IN THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 749892 | LEVEL 1 EQUATOR BLOWERS | SYSTEM, THERMAL REGULATING | DWJ | ST PAUL | EQ-5000-CN-230V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |