MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-04-25 for OLYMPIC WARM SCALE 56328 manufactured by Natus Medical Inc..
[73736979]
The customer did not have a service history for this device, and there was no record of the unit ever being returned to natus for repair or service. Very little dust was observed in the unit, and the air inlet filter was missing. When measured, the resistance of the heating coil was within the specification resistance range of 72 +/- 2 ohms for this heating coil. The warm scale cover was then removed and the internal electronics, including fuses, pcas, wiring, battery and connections were all checked for signs of obvious damage or heat stress. Other than the heating coil, no other internal damage was observed. The unit was then powered on briefly, and it was confirmed that proper voltages were being applied to the various pcas. No overheating and/or odors were detected. The damaged/stressed heater element showed both elongation and sagging of the heater coils. The heater coil elongation resulted in the failure of the unit to regulate the temperature of the newborn warming shelf to the expected temperature of approximately 93 degrees fahrenheit. Running under steady-state conditions, the plastic warming shelf reached a temperature of 129. 6 degrees fahrenheit without the fan filter, as received from customer. When the filter was installed, the steady-state temperature of the shelf reached 141 degrees fahrenheit. It was observed that after reaching steady-state, the warm scale continuously supplied power to the heating coil. This can be explained by the fact that the heating coils were spaced much further apart in the region of the thermistor sensor assembly than in the regions where thermocouples were located, resulting in a sensed air temperature of approximately 79 degrees f, without air filter and 80. 5 degrees f with the air filter. This temperature is not high enough regulate the new born shelf temperature to 93 degrees f as suggested in the instruction manual or to trip the over-temperature cutoff value of 103 degrees. This malfunction is the result of heating coil elongation in the area of the thermistor sensor assembly. The subject device has been scrapped and given to natus qa for analysis and root cause investigation. The customer has been provided a replacement unit. Natus is currently conducting an ongoing investigation into this malfunction and will follow up with supplemental reports as additional information is obtained.
Patient Sequence No: 1, Text Type: N, H10
[73736980]
On (b)(6) 2017, the customer reported that a warm scale was being returned to natus for service. The unit required calibration and had a damaged power cord. Additionally, a burning smell was detected from the unit. When the unit was received at natus for the damaged power cord and calibration, no adverse events or other malfunctions were reported. An initial determination to not report this event was determined and documented, but an investigation was launched due to the report of the burning smell. The unit was visually inspected by qa and the repair depot technician prior to the start of the investigation. Before disassembly, the warm scale was powered up for several minutes, and there was no detected burning odor. The reported power cord damage was determined to be superficial with no risk, but when the warm scale was evaluated at the natus repair depot, the returned unit showed evidence of possible thermal stress / damage to the heater element.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00301 |
| MDR Report Key | 6520062 |
| Report Source | USER FACILITY |
| Date Received | 2017-04-25 |
| Date of Report | 2017-02-10 |
| Date Mfgr Received | 2017-02-10 |
| Device Manufacturer Date | 2006-11-29 |
| Date Added to Maude | 2017-04-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEFFREY MANTKOWSKI |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685143 |
| Manufacturer G1 | NATUS MEDICAL INC. |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPIC WARM SCALE |
| Generic Name | WARM SCALE 28 |
| Product Code | FRW |
| Date Received | 2017-04-25 |
| Returned To Mfg | 2017-02-17 |
| Model Number | 56328 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INC. |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-25 |