MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-08 for OLYMPIC PASTEURMATIC 3000 007169 52640 manufactured by Natus Medical Inc.
[3135779]
The heaters inside the device stayed on after the customer turned off the power. Later, when the customer returned to the unit, the heaters were engaged (there was no water in the system). The device showed a configuration error stating "heating indicated". The front basket shield melted and the heaters and heater breakers turned purple. The main breaker switch was turned off to disengage the heaters. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10459375]
The cause of the malfunction is most likely a faulty k2 relay. Natus technical service requested that the biomed department turn the main breaker back on and fill the device halfway with water until the k1 relay engaged. They powered off the device and the k1 relay stayed engaged. Once biomed replaced the k2 relay, the k1 relay operated correctly. Suspect relay has been returned to natus for eval, along with a printout of the last 50 cycles from the device. Experiments will be run to try to simulate the event. A follow up report will be submitted when add'l info is available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3018859-2013-00002 |
| MDR Report Key | 2961303 |
| Report Source | 05 |
| Date Received | 2013-02-08 |
| Date of Report | 2013-01-10 |
| Date of Event | 2013-01-09 |
| Date Mfgr Received | 2013-01-10 |
| Device Manufacturer Date | 2012-05-20 |
| Date Added to Maude | 2013-04-22 |
| 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 | THERESE LEGGIERE |
| Manufacturer Street | 5900 FIRST AVE., SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPIC PASTEURMATIC 3000 |
| Generic Name | PASTEURIZER |
| Product Code | LDS |
| Date Received | 2013-02-08 |
| Returned To Mfg | 2013-01-24 |
| Model Number | 007169 |
| Catalog Number | 52640 |
| Lot Number | NOT APPLICABLE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC |
| Manufacturer Address | SEATTLE WA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-08 |