MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-07-20 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular System Corp.
[2830579]
The service repair technician reported that during routine testing of the device at the service center, the battery pack that was broken at bottom side and leaking battery acid. There was no pt involvement or harm to the user.
Patient Sequence No: 1, Text Type: D, B5
[10054092]
Eval is in progress, but not yet concluded. The reported complaint was confirmed by the field service rep (fsr). The repair center replaced the battery pack.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2012-01030 |
| MDR Report Key | 2670255 |
| Report Source | 07 |
| Date Received | 2012-07-20 |
| Date of Report | 2012-06-27 |
| Date of Event | 2012-06-27 |
| Date Mfgr Received | 2012-06-27 |
| Device Manufacturer Date | 2002-09-01 |
| Date Added to Maude | 2012-08-06 |
| 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 | KIPP DURBIN |
| Manufacturer Street | 6200 JACKSON RD |
| Manufacturer City | ANN ARBOR MI 48103 |
| Manufacturer Country | US |
| Manufacturer Postal | 48103 |
| Manufacturer Phone | 7346634145 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUMO CDI 100 MONITOR |
| Product Code | DTY |
| Date Received | 2012-07-20 |
| Returned To Mfg | 2011-12-05 |
| Model Number | 100 |
| Catalog Number | 100 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEM CORP |
| Manufacturer Address | ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-20 |