FDA Adverse Event
Malfunction
Summary report: N
COMPRESSOR MINI
MDR report key: 15713169
·
Received November 2, 2022
Report
- Report Number
- 8010042-2022-01910
- Event Type
- Malfunction
- Date Received
- November 2, 2022
- Date of Event
- October 16, 2022
- Report Date
- November 2, 2022
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- BTI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE REPORTED ISSUE WITH THE COMPRESSOR FAILING TO POWER ON WAS CONFIRMED DURING EVALUATION OF THE PROVIDED PROBLEM DESCRIPTION. SERVICE REPORT AND PICTURES ARE NOT PROVIDED. OUR FSE (FIELD SERVICE ENGINEER) WAS ON-SITE TO INVESTIGATE THE ISSUE FURTHER AND FOUND OUT THAT THE COMPRESSOR'S FUSES WERE DEFECTIVE AND REQUIRED REPLACEMENT. AFTER REPLACEMENT THE COMPRESSOR STARTED TO WORK PROPERLY. NO PARTS WERE RETURNED FOR FURTHER INVESTIGATION. SINCE NO PARTS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE COMPRESSOR DID NOT POWER ON. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF.#: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2874874 | COMPRESSOR MINI | COMPRESSOR, AIR, PORTABLE | BTI | MAQUET CRITICAL CARE AB | COMPR MINI 230V 50HZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose |