MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2011-08-12 for STERI-PROBE 491B 29622 manufactured by Cincinnati Sub-zero Products, Inc..
[2172415]
The customer stated "we have had another probe issue. This one was a bit different. The machine alarmed twice for the probe ("check probe") and was easily reset. The thing we did notice was that the baby's temp was migrating a great deal from 31. 1-33. 7. The 31. 1 is much too low. Because of this, we went ahead and changed the probe when we had the second alarm even though it reset without trouble. After the probe change, the temperatures stabilized between 32. 6 and 33. 7 as of this am. " the customer went on to say that they will be adding this to their medsun (fda) report. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[9462512]
The related complaint ((b)(4)) was received on (b)(4) 2011, followed by a user facility report, which we received on (b)(4) 2011. The probe lot number ((b)(4)) was traced back to alpha sensors, inc as the mfr. The investigation of a similar probe showed that when we moved the probe slightly from side to side, the pt temperature display became erratic and would not maintain a constant reading. Once movement of the probe stopped, the pt temperature reading again responded as expected. The failure mode seemed to be confirmed as similar to one experienced by the probes in the past. The probe had an intermittent connection at the rj-11 connection due to a mfg defect by alpha sensors, inc. Csz made these probes obsolete in (b)(4) 2009 and has scrapped all probes in stock. Csz is no longer a mfr of temperature probes, however, csz distributes temperature probes mfg by measurement specialties. In (b)(4) 2009, csz implemented a correction that was communicated to the customer who filed a complaint and to whom has ordered new temperature probes. Csz has performed health hazard eval and made a decision to recall these probes. Csz will work with fda district recall coord and initiate a recall as soon as possible. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1516825-2011-00011 |
| MDR Report Key | 2238408 |
| Report Source | 00,06 |
| Date Received | 2011-08-12 |
| Date of Report | 2011-07-13 |
| Date of Event | 2011-07-12 |
| Date Mfgr Received | 2011-07-13 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2012-06-18 |
| 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 | PRADEEP GUPTA |
| Manufacturer Street | 12011 MOSTELLER RD. |
| Manufacturer City | CINCINNATI OH 45241 |
| Manufacturer Country | US |
| Manufacturer Postal | 45241 |
| Manufacturer Phone | 5137728810 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | CSZ FA2011-009 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERI-PROBE |
| Generic Name | RECTAL/ESOPHAGEAL TEMPERATURE PROBE |
| Product Code | BZT |
| Date Received | 2011-08-12 |
| Model Number | 491B |
| Catalog Number | 29622 |
| Lot Number | D527632 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CINCINNATI SUB-ZERO PRODUCTS, INC. |
| Manufacturer Address | CINCINNATI OH 45241 US 45241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-12 |