FDA Adverse Event
Malfunction
Summary report: N
HUT EXT DR FINAL ASSY-STANDARD
MDR report key: 3140064
·
Received May 29, 2013
Report
- Report Number
- 1518293-2013-00107
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Date of Event
- May 2, 2013
- Report Date
- May 29, 2013
- Manufacturer
- LIEBEL - FLARSHEIM CO.
- Product Code
- IXR
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
ON (B)(6) 2013 CUSTOMER STATES VIA PHONE THAT DURING A STENT EXCHANGE ON A FEMALE PATIENT IN HER SEVENTIES BOTH ROOM MONITORS FAILED. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT INCIDENT AND CHECK PLACEMENT BY THE COMPUTER MONITOR IN THE CONTROL ROOM WHEN THE PROCEDURE WAS FINISHED. NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 234738 | HUT EXT DR FINAL ASSY-STANDARD | IXR | LIEBEL - FLARSHEIM CO. | HUT EXT DR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |