MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-15 for CAPITAL TEMP PUMP PROFESSIONAL TP700 manufactured by Stryker Medical-kalamazoo.
[145215198]
The patient condition prior to the alleged incident was not disclosed, however, it was identified that there were no pre-existing conditions that would have made the patient susceptible to burns. The patient was immobile during her stay at the hospital and had to have assistance for all meals and movement. The patient had alleged shoulder pain prior to use of the t-pump and a physician ordered heat therapy to be applied but did not indicate the parameters of use. The t-pump was used with a mul-t-pad. The model and lot of the mul-t-pad were not recorded at the time of the event. The t-pump was alleged to be set at 100 degrees f (38 degrees c) and was used continuously with a 20 minute cycle for the night. The patient was put to bed between 17:30-18:30 on march 2nd and was then woken at 7:25 on march 3rd. There were no checks of the patients skin recorded during the time she was put to bed and the time she was awoken. The patient was allegedly diagnosed with a burn wound that was rinsed with sterile saline and had a foam dressing applied. The wound was noted to be closed and healed on march 19th. Information was provided to the user facility that the patient's skin should be checked regularly to ensure the condition is appropriate to continue therapy.
Patient Sequence No: 1, Text Type: N, H10
[145215199]
A patient had superficial burns to her back and partial thickness burns to (2) areas with the worst over the left scapula. The patient had wound care provided following the event consisting of xerofoam to blisters with an optifoam gentle dressing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2019-00566 |
| MDR Report Key | 8613538 |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-03-03 |
| Date Mfgr Received | 2019-04-17 |
| Device Manufacturer Date | 2013-12-17 |
| Date Added to Maude | 2019-05-15 |
| 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 | MR. BRIAN THOMPSON |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAPITAL TEMP PUMP PROFESSIONAL |
| Generic Name | PACK, HOT OR COLD, WATER CIRCULATING |
| Product Code | ILO |
| Date Received | 2019-05-15 |
| Catalog Number | TP700 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-15 |