FDA Adverse Event
Malfunction
Summary report: N
AUTOCLAVABLE INTERNAL HANDLES
MDR report key: 317755
·
Received February 22, 2001
Report
- Report Number
- 1220908-2001-00262
- Event Type
- Malfunction
- Date Received
- February 22, 2001
- Report Date
- January 25, 2001
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- LDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DURING A SALES DEMONSTRATION OF THE DEVICE BY A ZOLL SALES REPRESENTATIVE TO A POTENTIAL CUSTOMER, THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE. THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7069 | AUTOCLAVABLE INTERNAL HANDLES | INTERNAL PADDLE | LDD | ZOLL MEDICAL CORPORATION | 80040023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |