D
Patient 1
THE DISTRIBUTOR REPORTED BURNING SMELL AND SMOKE FROM AN AIR TECHNIQUES PERI-PRO FILM PROCESSOR DURING A SERVICE CALL BY ONE OF THEIR TECH'S AFTER REPLACING THE HEATER PAD IN THE UNIT.
MAUDE MDR 4095494
- MDR report key
- 4095494
- Report number
- 2428225-2014-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-01-04
- Date received
- 2014-09-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Address
- 1295 WALT WHITMAN RD. MELVILLE NY 11747 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 | PERI-PRO | FILM PROCESSOR | AIR TECHNIQUES, INC. | IXW | 94000M | 94000 | NA | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-09-08 | 0 | 1. O |
Event Narratives#
N
Patient 1
ON (B)(6) 2013, A CUSTOMER REPORTED A PERI-PRO III (P/N 94000M) DRYER SECTION OVERHEATED CAUSING THE FAN AND PLASTIC COVER TO MELT. THERE WERE NO INJURIES OR HEALTH HAZARD REPORTED. AIR TECHNIQUES CONTACTED DR (B)(6) OFFICE. (B)(6), AN EMPLOYEE OF DR. (B)(6) TEAM, CONFIRMED THE REPORTED INCIDENT. SHE SAID KODAK SIZE #2 FILM WAS STUCK IN THE DRYER SECTION, LYING ON THE HEATER GRILL, AND STARTED TO SMOKE. THE UNIT IMMEDIATELY SHUT OFF. UNDER NORMAL OPERATING CONDITIONS, FILM FALLING OUT OF THE DRYER TRANSPORT SECTION ONTO THE HEATER DRYER GRILL WILL CAUSE THE FILM TO MELT. THE MELTING PRODUCES A MELTED PLASTIC SMELL, BUT NO SMOKE OR HAZARD WAS CREATED.