MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-21 for DICKSON PB-104 manufactured by Whitehall Mfg. / Div. Of Acorn Engineering Co..
[87497821]
The device referenced in the report was returned to our facility for evaluation. During the evaluation, it was confirmed that the device exceeded our highest temperature range of 140 to 150? F by an additional 50? F. The device malfunction appears to have been caused by a faulty operating thermostat. Our original manufacturing test records indicate that the device operated normally at the time. No other malfunction was identified.
Patient Sequence No: 1, Text Type: N, H10
[87497822]
Customer states that the device malfunctioned and was making the paraffin wax get too hot. This could potentially lead to a patient getting burned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000323249-2017-00001 |
| MDR Report Key | 6882427 |
| Date Received | 2017-09-21 |
| Date of Report | 2017-09-20 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-01-14 |
| Device Manufacturer Date | 2014-10-22 |
| Date Added to Maude | 2017-09-21 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOSE MUNOZ |
| Manufacturer Street | 15125 PROCTOR AVE. |
| Manufacturer City | CITY OF INDUSTRY CA 91746 |
| Manufacturer Country | US |
| Manufacturer Postal | 91746 |
| Manufacturer Phone | 8007827706 |
| Manufacturer G1 | FABRICACION Y MANUFACTURAS DE MEXICO S.A.DE C.V. |
| Manufacturer Street | CALLE MAQUILADORAS NO. 1387-1 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA, BAJA CALIFORNIA 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DICKSON |
| Generic Name | PARAFFIN BATH |
| Product Code | IMC |
| Date Received | 2017-09-21 |
| Returned To Mfg | 2015-02-26 |
| Model Number | PB-104 |
| Operator | PHYSICAL THERAPIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WHITEHALL MFG. / DIV. OF ACORN ENGINEERING CO. |
| Manufacturer Address | 15125 PROCTOR AVE. CITY OF INDUSTRY 91746 US 91746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-21 |