MCGRATH MAC
Report
- Report Number
- 3010244187-2024-00010
- Event Type
- Injury
- Date Received
- May 15, 2024
- Date of Event
- May 10, 2024
- Report Date
- August 8, 2024
- Manufacturer
- AIRCRAFT MEDICAL LIMITED
- Product Code
- CCW
- UDI-DI
- 15060272980020
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- 2936999-07-22-2024-001-R
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
D10 CONCOMITANT PRODUCTS: 340-000-000, MCGRATH 3.6V BATTERY 340-000-000, (LOT #H22083104). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION: B5, G3, H3, H6, H7, H9 (ASSOCIATED RES NUMBER (B)(4)) H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. PHOTOS AND DEVICES WERE AVAILABLE FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOS SHOWED SIGNIFICANT DAMAGE TO THE HANDLE. SCORCHING WAS EVIDENT AND DEBRIS WAS THROWN OVER A LARGE AREA. THE BATTERY CELL WAS TORN OPEN AND SHOWED SCORCHING. INTERNAL COMPONENTS TO THE BATTERY WERE SEEN AS HAVING BEEN EJECTED FROM THE BATTERY MANY FEET FROM THE EVENT SPACE. THE BATTERY COVER WAS IN MULTIPLE PIECES. THE PRODUCT SERIAL NUMBER AND LABELING REMAIN INTACT AND LEGIBLE. THE REMNANTS OF THE HANDLE AND BATTERY WERE RETURNED. (B)(4) OTHER BATTERIES FROM THE CUSTOMER SITE WERE ALSO RETURNED FOR INVESTIGATION SUPPORT. ALL (B)(4) UNITS SHOWED NO VISUAL ANOMALIES. ANALYSIS AND TESTING ON THE RETAINED SAMPLES OF THE SAME LOT WITH TWO MCGRATH MAC HANDLES AND ONE NEXT-GENERATION MCGRATH MAC HANDLE REVEALED THAT THE MCGRATH MAC DEVICE BATTERY MANAGEMENT SYSTEM WAS NOT SUFFICIENT TO MITIGATE AGAINST DEPLETION OF THE BATTERY VOLTAGE. IT WAS REPORTED THAT MCGRATH DEVICE WAS REMOVED FROM ITS BOX IN THE AIRWAY TROLLEY IN THE HIGH DEPENDENCY UNIT DEPARTMENT AND IT WOULD NOT TURN ON. AFTER ATTEMPTS TO POWER ON THE DEVICE, THE UNIT WAS HANDED TO ANOTHER NURSE AND THE UNIT EXPLODED FROM THE BATTERY PORTION OF THE DEVICE. THERE WERE BURNS TO THE NURSE¿S HANDS AND POSSIBLY THE CHEST. THERE WAS A LOUD BANG PRODUCED, INJURING FOUR OTHERS NEARBY. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS DETERMINED TO BE DEVICE DESIGN RELATED. INTERNAL PROCESS IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS ISSUE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ACCORDING TO THE REPORTER, THE NURSE REMOVED THE MCGRATH DEVICE FROM ITS UNIT BOX IN THE AIRWAY TROLLEY IN THE MORNING. IT WAS STORED IN BOX IN A DRAWER AWAY FROM DIRECT SUNLIGHT IN THE HDU (HIGH DEPENDENCY UNIT) DEPARTMENT. THE NURSE THEN MOVED THE DEVICE TO THE DESK AT THE NURSE¿S STATION TO INSPECT IT PRIOR TO USE. WHEN THE NURSE INITIALLY WENT TO POWER ON THE MCGRATH, IT DID NOT RESPOND DESPITE PRESSING THE POWER BUTTON DOWN FOR ¿SEVERAL MOMENTS¿. THE DEVICE WAS HANDED TO A COLLEAGUE TO EXAMINE. WHEN THIS NURSE PICKED UP THE DEVICE, THE BATTERY OF THE DEVICE EXPLODED IN THE NURSE¿S HAND, GENERATED ¿AN EXTREMELY LOUD BANG¿, AND EMITTED SMOKED. THERE WERE BURNS TO THE NURSE¿S CHEST AND HANDS. THERE WERE ALSO BURNS TO THE NURSE¿S COLLEAGUE WHO WAS STANDING NEXT TO THE NURSE. DEBRIS WAS VISIBLE AT LEAST 10 FOOT FROM THE SITE OF THE BATTERY OF THE DEVICE EXPLODING. THESE 2 NURSES RECEIVED TREATMENT IN THE EMERGENCY DEPARTMENT ALONG WITH 4 OTHER COLLEAGUES WHO APPEARED TO BE EXPERIENCING TINNITUS FROM THE NOISE OF THE EXPLOSION AND SHOCK FROM WITNESSING THE INCIDENT.
ACCORDING TO THE REPORTER, THE NURSE REMOVED THE MCGRATH DEVICE FROM ITS UNIT BOX IN THE AIRWAY TROLLEY IN THE MORNING OF (B)(6) 2024. IT WAS STORED IN BOX IN A DRAWER AWAY FROM DIRECT SUNLIGHT IN THE HDU (HIGH DEPENDENCY UNIT) DEPARTMENT. THE NURSE THEN MOVED THE DEVICE TO THE DESK AT THE NURSE¿S STATION TO INSPECT IT PRIOR TO USE. WHEN THE NURSE INITIALLY WENT TO POWER ON THE MCGRATH, IT DID NOT RESPOND DESPITE PRESSING THE POWER BUTTON DOWN FOR ¿SEVERAL MOMENTS¿. THE DEVICE WAS HANDED TO A COLLEAGUE TO EXAMINE. WHEN THIS NURSE PICKED UP THE DEVICE, THE BATTERY OF THE DEVICE EXPLODED IN THE NURSE¿S HAND, GENERATED ¿AN EXTREMELY LOUD BANG¿, AND EMITTED SMOKED. THERE WAS A REPORT OF A 'BAD' SMELL. THERE WERE BURNS TO THE NURSE¿S HANDS AND POSSIBLY THE CHEST (CHEST BURNS REMAIN UNCONFIRMED AT THIS TIME). DEBRIS WAS VISIBLE AT LEAST 10 FOOT FROM THE SITE OF THE BATTERY OF THE DEVICE EXPLODING. THE 2 NURSES RECEIVED TREATMENT IN THE EMERGENCY DEPARTMENT ALONG WITH 4 OTHER COLLEAGUES WHO APPEARED TO BE EXPERIENCING TINNITUS FROM THE NOISE OF THE EXPLOSION AND SHOCK FROM WITNESSING THE INCIDENT. THE NURSE HOLDING THE DEVICE WAS ADMITTED TO THE HOSPITAL WITH BILATERAL HAND BURNS AND LACERATIONS. THE NURSE UNDERWENT SURGERY THE FOLLOWING DAY AND FOREIGN BODIES (SHRAPNEL) WERE REMOVED FROM BOTH HANDS. THE OTHER STAFF MEMBERS WERE DISCHARGED. THE CUSTOMER STATED THAT THERE WERE DAILY CHECKS CARRIED OUT IN THE HDU ON THE DEVICE AND DEVICE WAS USED 1-2 TIMES PER MONTH.
ACCORDING TO THE REPORTER, THE NURSE REMOVED THE MCGRATH DEVICE FROM ITS UNIT BOX IN THE AIRWAY TROLLEY IN THE MORNING. IT WAS STORED IN BOX IN A DRAWER AWAY FROM DIRECT SUNLIGHT IN THE HDU (HIGH DEPENDENCY UNIT) DEPARTMENT. THE NURSE THEN MOVED THE DEVICE TO THE DESK AT THE NURSE¿S STATION TO INSPECT IT PRIOR TO USE. WHEN THE NURSE INITIALLY WENT TO POWER ON THE MCGRATH, IT DID NOT RESPOND DESPITE PRESSING THE POWER BUTTON DOWN FOR ¿SEVERAL MOMENTS¿. THE DEVICE WAS HANDED TO A COLLEAGUE TO EXAMINE. WHEN THIS NURSE PICKED UP THE DEVICE, THE BATTERY OF THE DEVICE EXPLODED IN THE NURSE¿S HAND, GENERATED ¿AN EXTREMELY LOUD BANG¿, AND EMITTED SMOKED. THERE WERE BURNS TO THE NURSE¿S CHEST AND HANDS. DEBRIS WAS VISIBLE AT LEAST 10 FOOT FROM THE SITE OF THE BATTERY OF THE DEVICE EXPLODING. THE 2 NURSES RECEIVED TREATMENT IN THE EMERGENCY DEPARTMENT ALONG WITH 4 OTHER COLLEAGUES WHO APPEARED TO BE EXPERIENCING TINNITUS FROM THE NOISE OF THE EXPLOSION AND SHOCK FROM WITNESSING THE INCIDENT. THE NURSE HOLDING THE DEVICE UNDERWENT SURGERY THE FOLLOWING DAY AND THE OTHER STAFF MEMBERS WERE DISCHARGED.
ACCORDING TO THE REPORTER, THE NURSE REMOVED THE MCGRATH DEVICE FROM ITS UNIT BOX IN THE AIRWAY TROLLEY IN THE MORNING. IT WAS STORED IN BOX IN A DRAWER AWAY FROM DIRECT SUNLIGHT IN THE HDU (HIGH DEPENDENCY UNIT) DEPARTMENT. THE NURSE THEN MOVED THE DEVICE TO THE DESK AT THE NURSE¿S STATION TO INSPECT IT PRIOR TO USE. WHEN THE NURSE INITIALLY WENT TO POWER ON THE MCGRATH, IT DID NOT RESPOND DESPITE PRESSING THE POWER BUTTON DOWN FOR ¿SEVERAL MOMENTS¿. THE DEVICE WAS HANDED TO A COLLEAGUE TO EXAMINE. WHEN THIS NURSE PICKED UP THE DEVICE, THE BATTERY OF THE DEVICE EXPLODED IN THE NURSE¿S HAND, GENERATED ¿AN EXTREMELY LOUD BANG¿, AND EMITTED SMOKED. THERE WERE BURNS TO THE NURSE¿S CHEST AND HANDS. DEBRIS WAS VISIBLE AT LEAST 10 FOOT FROM THE SITE OF THE BATTERY OF THE DEVICE EXPLODING. THE 2 NURSES RECEIVED TREATMENT IN THE EMERGENCY DEPARTMENT ALONG WITH 4 OTHER COLLEAGUES WHO APPEARED TO BE EXPERIENCING TINNITUS FROM THE NOISE OF THE EXPLOSION AND SHOCK FROM WITNESSING THE INCIDENT. THE NURSE HOLDING THE DEVICE WAS ADMITTED TO THE HOSPITAL WITH BILATERAL HAND BURNS AND LACERATIONS. THE NURSE UNDERWENT SURGERY THE FOLLOWING DAY AND FOREIGN BODIES (SHRAPNEL) WERE REMOVED FROM BOTH HANDS. THE OTHER STAFF MEMBERS WERE DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 647699 | MCGRATH MAC | LARYNGOSCOPE, RIGID | CCW | AIRCRAFT MEDICAL LIMITED | 300-000-000 | 15060272980020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H | SEE H11. |