SERVO-U
Received Dec 19, 2022 · Event occurred Dec 1, 2022
Report 8010042-2022-02259 · MDR key 16004148
Device
Generic name
Chamber, Hyperbaric
Manufacturer
Maquet Critical Care AbModel number
SERVO-UCatalog number
6694800
Product problems
- Contamination /Decontamination Problem
- Contamination /Decontamination Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE VENTILATOR WAS INVESTIGATED ON-SITE AND FOUND PRESENCE OF LIQUID/MEDICINES SPILLED INTO THE PRESSURE TRANSDUCER PRINTED CIRCUIT BOARDS (PCBS). THE PRESSURE TRANSDUCER PCBS WER DEFECTIVE AND REPLACED. AFTER REPLACEMENT, THE VENTILATOR PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS, RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE. THE PROVIDED PICTURES CONFIRMED THE REPORTED LIQUID/MEDICINES INGRESS INTO THE PCBS. THE PROVIDED PICTURES CONFIRMED THE LIQUID ON THE PCBS. INGRESS OF LIQUID/CORROSIVE SUBSTANCE ON PC BOARDS CAN CAUSE FAILURE/SHORT CIRCUITS, WHICH MIGHT LEAD TO A VENTILATOR MALFUNCTION. THE PROVIDED PICTURES RAVELED SIGNS OF LIQUID SPILL. THERE IS NO INFORMATION ON HOW THE LIQUID SPILL ENTERED THE VENTILATOR OR WHAT KIND OF LIQUID SPILL IT WAS. OUR CONCLUSION IS THAT THE REPORTED PROBLEM WAS CAUSED BY DEFECTIVE PRESSURE TRANSDUCER PCBS AS A RESULT OF WATER INGRESS INTO THE VENTILATOR.
Description of Event or Problem
IT WAS REPORTED THAT THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THE VENTILATOR WAS CONTAMINATED WITH WATER/LIQUID. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF.#: (B)(4).