MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-12 for REOCOR D 365529 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[123572694]
We received a voluntary medwatch report from the fda. The report was sent in from (b)(6) health ((b)(4)). The report is: when a (b)(6) year old male was being taken off cardio-pulmonary bypass an external pacemaker was needed. When the pacemaker was turned on, it just flashed all the lights and would not pace. The nurse had to run out of the room for another pacemaker. The malfunctioning pacemaker delayed patient care and extended the cardio-pulmonary bypass time. The device was sent to the hospital's biomed team where the device passed all the manufacture specs. They did notice that the mode turn knob was hard to turn so they decided to exchange the device. The serial number of this device under complaint was not provided by the hospital. The hospital has also said that this device was not returned for an analysis. It is unclear if the device was returned or not.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2018-03496 |
| MDR Report Key | 7962121 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-12 |
| Date of Report | 2018-09-25 |
| Date Mfgr Received | 2019-01-31 |
| Date Added to Maude | 2018-10-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 6024 JEAN ROAD |
| Manufacturer City | LAKE OSWEGO OR 97035 |
| Manufacturer Country | US |
| Manufacturer Postal | 97035 |
| Manufacturer Phone | 8772459800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REOCOR D |
| Generic Name | EXTERNAL PACEMAKER |
| Product Code | OVJ |
| Date Received | 2018-10-12 |
| Model Number | 365529 |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | WOERMANNKEHRE 1 BERLIN D-12359 GM D-12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-10-12 |