N
Patient 1
GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
MAUDE MDR 8270167
- MDR report key
- 8270167
- Report number
- 1121732-2019-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-12-25
- Date received
- 2019-01-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JOHN SZALINSKI
- Address
- 3000 N GRANDVIEW BLVD. WAUKESHA WI US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GIRAFFE OMNIBED | NEONATAL INCUBATOR | OHMEDA MEDICAL | FMZ | 6650-0004-901 | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-01-23 | 0 | 1. D |
Event Narratives#
D
Patient 1
THE UNIT WENT INTO ALLEGED "FAN FAILURE" ALARM SHORTLY AFTER THE PATIENT, A (B)(6) EARLY NEWBORN, WAS PLACED IN THE OMNIBED IN THE INCUBATOR POSITION. BECAUSE OF THE FAN FAILURE ALARM, THE CUSTOMER HAD TO MOVE THE PATIENT FROM ONE BED TO ANOTHER. THE CUSTOMER STATED THAT ONCE THE PATIENT WAS MOVED, THE INFANT REQUIRED A CHEST TUBE AND THEN VENTILATION ON THE EVENING OF (B)(6). ON (B)(6), THE PATIENT PASSED AWAY.
N
Patient 1
A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM BUT DID NOT CONFIRM THE REPORTED ISSUE. GE HEALTHCARE PRODUCT ENGINEERING PERFORMED AN INVESTIGATION OF THIS EVENT. THE FAN FAILURE ALARM CAN GET TRIGGERED WHEN THE FAN IS NOT PUSHED DOWN FAR ENOUGH ONTO THE RUBBER HUB. GIRAFFE OMNIBED CLEANING & CARE GUIDELINES (M1131904 REV A) COVERS THE PROPER REASSEMBLY INSTRUCTIONS OF THE FAN AFTER CLEANING. GE HEALTHCARE ENGINEERING DETERMINED THAT IT IS LIKELY THAT THE IMPROPER SEATING OF FAN OR FAN HUB CONTRIBUTED TO THE INTERMITTENT "¿?FAN FAILURE ALARM¿?." THE BIOMED STATED THAT THIS PROBLEM IS NOTICED SPORADICALLY WITH OTHER GIRAFFE OMNIBEDS IN THE NICU AS WELL AFTER THE FAN ASSEMBLY WAS DIS-ASSEMBLED AND RE-ASSEMBLED AFTER CLEANING. THEREFORE, THE PROBABLE ROOT CAUSE FOR THE INTERMITTENT FAN FAILURE ALARM COULD BE FAN OR FAN HUB NOT SEATED PROPERLY BY THE HOSPITAL STAFF. THE INFANT'S STATUS WAS FRAGILE AND UNSTABLE FROM TIME OF DELIVERY AND THROUGHOUT THE TIME IN THE NICU. THE INFANT WAS INTUBATED PRIOR TO THE MOVE TO THE NEW BED. AFTER THE MOVE, THE PATIENT CONTINUED TO DE-SATURATE AND REQUIRED A CHEST TUBE. THE UNIT RAISED THE FAN FAILURE ALARM AS DESIGNED. THEREFORE, THE GIRAFFE OMNIBED DID NOT CAUSE OR CONTRIBUTE TO THE INFANT DEMISE.