FDA Adverse Event
Malfunction
Summary report: N
SWITCHED INTERNAL PADDLES - 7.5 CM
MDR report key: 1961251
·
Received December 21, 2010
Report
- Report Number
- 1218950-2010-02680
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Report Date
- December 3, 2010
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- LDD
- PMA / PMN Number
- K021453
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THEY OBSERVED A GREATER THAN EXPECTED MUSCULAR RESPONSE FROM A PT WHEN ENERGY WAS DELIVERED VIA INTERNAL PADDLES. NO OTHER PT IMPACT WAS REPORTED. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEY OBSERVED A GREATER THAN EXPECTED MUSCULAR RESPONSE FROM A PT WHEN ENERGY WAS DELIVERED VIA INTERNAL PADDLES. NO OTHER PT IMPACT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWITCHED INTERNAL PADDLES - 7.5 CM | LDD | PHILIPS HEALTHCARE | M4741A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |