MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-03 for TERUMO CDI 100 MONITOR 5330 manufactured by Terumo Cardiovascular Systems Corp..
[20699510]
It was reported by the customer that the battery was cracked on the blood parameter monitor (bpm). This was a backup battery and was found while walking by the battery sitting on a charger. This was not pertaining to any case or setup, and there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[21005136]
The reported issue was confirmed by visual inspection. Corrosion was evident on the battery where it was exposed. This product is being phased out in the global market. Service and replacement parts are no longer available. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2013-00689 |
| MDR Report Key | 3214221 |
| Report Source | 05,06 |
| Date Received | 2013-07-03 |
| Date of Report | 2013-06-11 |
| Date of Event | 2013-06-11 |
| Date Mfgr Received | 2013-06-11 |
| Date Added to Maude | 2013-08-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAN WINDER |
| 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 | 2013-07-03 |
| Returned To Mfg | 2013-06-27 |
| Model Number | 5330 |
| Catalog Number | 5330 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
| Manufacturer Address | ANN ARBOR MI 48103 US 48103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-03 |