MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-07-07 for DIAGNOST 76 70638 manufactured by Philips Medical Systems Dmc Gmbh.
[2132563]
The customer reported that the cable holder was broken.
Patient Sequence No: 1, Text Type: D, B5
[9205465]
The investigation is currently ongoing and conclusions will be sent in a follow up report to the fda. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768251-2011-00041 |
| MDR Report Key | 2182213 |
| Report Source | 05 |
| Date Received | 2011-07-07 |
| Date of Report | 2011-06-12 |
| Date Mfgr Received | 2011-06-12 |
| Date Added to Maude | 2011-11-07 |
| 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 | DOMINIC SIEWKO |
| Manufacturer Street | 3000 MINUTEMAN RD MS 4-135 |
| Manufacturer City | ANDOVER MA 018101099 |
| Manufacturer Country | US |
| Manufacturer Postal | 018101099 |
| Manufacturer Phone | 9786597936 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAGNOST 76 |
| Product Code | IXL |
| Date Received | 2011-07-07 |
| Model Number | 70638 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS DMC GMBH |
| Manufacturer Address | ROENTGENSTR. 24 HAMBURG 22335 GM 22335 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-07 |