D
Patient 1
THE CUSTOMER REPORTED THE NEEDLE WILL NOT REST AT ZERO ON THE CUFFLATOR DURING SET-UP. THE CUSTOMER DID NOT SPECIFY THE DATE WHEN THIS WAS DISCOVERED. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.
MAUDE MDR 2903082
- MDR report key
- 2903082
- Report number
- 2020362-2012-00661
- Event key
- 0
- Event type
- 3
- Date received
- 2012-11-30
- 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#
- Contact
- PAM WAMPLER
- Address
- 5635 PECK RD. ARCADIA CA 91006 US
- Phone
- 626-626-6264
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CUFFLATOR ENDO TUBE INFLATOR & MANOMETER | J. T. POSEY CO. | BSK | 8199 | 8199 | 1213741 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-11-30 | 0 |
Event Narratives#
N
Patient 1
EVAL RESULTS: EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE. THE NEEDLE DOES NOT REST AT ZERO. WHEN PRESSURE IS ATTEMPTED THE NEEDLE MOVES UP ABRUPTLY BUT COMES BACK DOWN ON ITS OWN. THE NEEDLE STOPS AT 98 ON THE DIAL PLATE. THE RUBBER PROTECTIVE RING IS MISSING ON THE CUFFLATOR. NOTE: THE INSTRUCTIONS FOR USE STATE: THE CUFFLATOR SHOULD BE CALIBRATED ANNUALLY, OR IF MEASUREMENTS ALL OUTSIDE OF A SPECIFIC RANGE, OR IF THE CUFFLATOR NEEDLE DOES NOT INDICATE A READING OF ZERO WHEN NOTHING IS CONNECTED, OR IF THE UNIT IS EVER DROPPED. NEVER OPEN THE CUFFLATOR BODY. (B)(4).