BABYLOG VN800
Report
- Report Number
- 9611500-2025-00644
- Event Type
- Injury
- Date Received
- November 24, 2025
- Date of Event
- October 24, 2025
- Report Date
- December 1, 2025
- Manufacturer
- DRÄGERWERK AG & CO. KGAA
- Product Code
- QOV
- UDI-DI
- 04048675542148
- PMA / PMN Number
- EUA201036
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
THE INVESTIGATION WAS BASED ON THE REPORTED INFORMATION. BASED ON THE INFORMATION THE BREATHING CIRCUIT WAS INCORRECTLY ASSEMBLED BY THE USER DURING SETUP. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. THE INSPIRATORY AND EXPIRATORY CONNECTIONS MEET THE REQUIREMENTS OF ISO 80601-2-12 AND ISO 5356-1. FURTHERMORE, THE INSPIRATORY AND EXPIRATORY PORT ARE MARKED WITH ARROWS INDICATING THE GAS FLOW DIRECTION AS A RISK MITIGATION MEASURE. THE INSTRUCTION FOR USE INCLUDES A CAUTION THAT INFORMS THE USER THAT HUMIDIFICATION IS INEFFECTIVE IF THE INSPIRATORY HOSE AND THE EXPIRATORY HOSE ARE CONNECTED TO THE WRONG PORT. ADDITIONALLY, THE TEST POINT TWO AND THREE OF THE SYSTEM TEST REQUIRES TO CHECK AND CONFIRM THE BREATHING CIRCUIT CONNECTION AND THE INSPECTION OF THE HUMIDIFIER. IN CASE OF THE USER REVERSE THE GAS OUTPUT PORT AND THE GAS RETURN PORT, NOT NOTICING THAT THE HUMIDIFIER IS IN THE EXPIRATORY LIMB THE BREATHING GAS HUMIDIFICATION IS INEFFECTIVE WHICH WOULD LED AFTER A TIME TO NECROSIS OF AIRWAY MUCOSA. THE RESULTS OF THE INVESTIGATION DID NOT REVEAL ANY NEW RISKS WHICH ARE NOT COVERED BY THE PRODUCT RISK MANAGEMENT FILE.
THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.
IT WAS REPORTED THAT THE VENTILATOR CIRCUIT HAD BEEN CONNECTED THE WRONG WAY ROUND DURING VENTILATION THERAPY, MEANING THE PATIENT MAY HAVE RECEIVED COLD, DRY AND INEFFECTIVE VENTILATION FOR UP TO 48 HOURS. DURING THIS TIME THE PATIENT NEEDED VERY HIGH PRESSURES, BECAME INCREASINGLY UNWELL, AND REQUIRED TWO REINTUBATIONS. ONCE THE CIRCUIT WAS CORRECTED, THE PATIENT DETERIORATED RAPIDLY AND WENT INTO CARDIAC ARREST, NEEDING CHEST COMPRESSIONS AND THREE DOSES OF ADRENALINE. IT WAS REPORTED THAT THE VENTILATORS WERE RELABELLED, TRAINING MATERIALS AND VIDEOS WERE RE-ISSUED, AND STAFF WAS PROVIDED WITH REFRESHER TRAINING. REPORTEDLY, THE VENTILATOR¿S SYSTEM-CHECK PASSED EVEN THOUGH THE INSPIRATORY AND EXPIRATORY LIMBS WERE CONNECTED THE WRONG WAY ROUND AND THE TWO PORTS LOOK ALMOST IDENTICAL ¿ BOTH WHITE, SIMILAR SIZE, AND LABELLED ¿INSP¿ AND ¿EXP¿ IN SMALL WHITE TEXT ON A BLUE BACKGROUND.
IT WAS REPORTED THAT THE VENTILATOR CIRCUIT HAD BEEN CONNECTED THE WRONG WAY ROUND DURING VENTILATION THERAPY, MEANING THE PATIENT MAY HAVE RECEIVED COLD, DRY AND INEFFECTIVE VENTILATION FOR UP TO 48 HOURS. DURING THIS TIME THE PATIENT NEEDED VERY HIGH PRESSURES, BECAME INCREASINGLY UNWELL, AND REQUIRED TWO REINTUBATIONS. ONCE THE CIRCUIT WAS CORRECTED, THE PATIENT DETERIORATED RAPIDLY AND WENT INTO CARDIAC ARREST, NEEDING CHEST COMPRESSIONS AND THREE DOSES OF ADRENALINE. IT WAS REPORTED THAT THE VENTILATORS WERE RELABELLED, TRAINING MATERIALS AND VIDEOS WERE RE-ISSUED, AND STAFF WAS PROVIDED WITH REFRESHER TRAINING. REPORTEDLY, THE VENTILATOR¿S SYSTEM-CHECK PASSED EVEN THOUGH THE INSPIRATORY AND EXPIRATORY LIMBS WERE CONNECTED THE WRONG WAY ROUND AND THE TWO PORTS LOOK ALMOST IDENTICAL ¿ BOTH WHITE, SIMILAR SIZE, AND LABELLED ¿INSP¿ AND ¿EXP¿ IN SMALL WHITE TEXT ON A BLUE BACKGROUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2557102 | BABYLOG VN800 | VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC | QOV | DRÄGERWERK AG & CO. KGAA | 8422500 | 04048675542148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Life Threatening | NA. |