MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2012-03-27 for AXIOHM PRINTER, UNIV W/ POWER SUPPLY ONLY 14-716 manufactured by Alere San Diego, Inc..
[14926534]
Caller alleged that the printer data cable was hot and soft as though melting. Printer was not printing and the data cable was hot to the touch. Customer described it as being "curling iron hot" and that the plastic sheath seems soft as though melting. No one was burned or injured by the cable. Technical services is replacing the data cable. Customer to return the faulty cable.
Patient Sequence No: 1, Text Type: D, B5
[15275613]
Investigation pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2012-00415 |
| MDR Report Key | 2509202 |
| Report Source | 00,05 |
| Date Received | 2012-03-27 |
| Date of Report | 2012-03-27 |
| Date of Event | 2012-02-28 |
| Date Mfgr Received | 2012-02-28 |
| Date Added to Maude | 2012-06-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CARMEN BERGELIN, MANAGER |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052256 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXIOHM PRINTER, UNIV W/ POWER SUPPLY ONLY |
| Product Code | CHH |
| Date Received | 2012-03-27 |
| Model Number | 14-716 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-27 |