MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-05-21 for TERUMO CDI 100 MONITOR manufactured by Terumo Cardiovascular System Corp.
[19192985]
It was reported that during the use of the device for a non-clinical activity, the monitor would not turn on. The unit has been in storage. There was no pt involvement.
Patient Sequence No: 1, Text Type: D, B5
[19466947]
Evaluation is in progress, but not yet concluded. The user facility's heart program was being restarted and the perfusionist (ccp) was checking the equipment. When the unit would not turn on, they noticed the battery was old and looked to be leaking.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1828100-2013-00528 |
| MDR Report Key | 3130100 |
| Report Source | 05,06 |
| Date Received | 2013-05-21 |
| Date of Report | 2013-04-30 |
| Date of Event | 2013-04-30 |
| Date Mfgr Received | 2013-04-30 |
| Date Added to Maude | 2013-07-29 |
| 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 | 2013-05-21 |
| Returned To Mfg | 2013-05-10 |
| Model Number | 100 |
| Catalog Number | 100 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2013-05-21 |