MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-10-04 for CONTROLLER, VEST 205 P205CM manufactured by Hill-rom Singapore.
[56402500]
In an abundance of caution, hill-rom is reporting the patient death as the patient used a hill-rom device in the hours preceding his death. Hill-rom contacted the user facility multiple times and was unable to get any additional information related to the device identity or incident details. We were unable to evaluate the device involved in this incident. The most common cause of spleen rupture is severe direct blunt trauma to the left upper abdomen or the left lower chest. The mechanism of action of the vest is not such that it produces forces equivalent to severe direct blunt trauma so the spleen rupture is unlikely attributed to the performance of the vest. There were no indications of a malfunction as reported by the family or facility. No further information is available on this incident or device at this time. A follow up report will be sent if further information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[56402501]
Hill-rom received a report from the patient's daughter stating, "the vest therapy was first prescribed and performed on (b)(6) 2016. Patient complained of the therapy being painful and stated so to either the nurse of respiratory "nurse". The nurse or respiratory "nurse" did not stop the treatment but made the comment that "there was only 5 minutes left of therapy. " over the course of the next several hours, the patient did not feel well and eventually coded and expired approximately 12 hours after the completion of therapy. " the device was at (b)(6) hospital at the time of the reported incident. This has been filed in our complaint handling system as (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008145987-2016-00003 |
| MDR Report Key | 5997878 |
| Report Source | OTHER |
| Date Received | 2016-10-04 |
| Date of Report | 2016-09-12 |
| Date of Event | 2016-04-23 |
| Date Mfgr Received | 2016-09-12 |
| Date Added to Maude | 2016-10-04 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL BURNETT |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129312901 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTROLLER, VEST 205 |
| Generic Name | THE VEST |
| Product Code | BYI |
| Date Received | 2016-10-04 |
| Model Number | P205CM |
| Operator | RESPIRATORY THERAPIST |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM SINGAPORE |
| Manufacturer Address | 1 YISHUN AVENUE 7 SINGAPORE, NORTH EAST 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-10-04 |