MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-04-30 for CONTROLLER, VEST 105 P105CM manufactured by .
[4475303]
The patient's father reported that during a treatment with the vest, his child who does not verbally communicate, appeared to cramp and his mouth was opened wide. He laid him down and within a couple of hours, he took him to the hospital. The vest was being administered in the patient's home by the caregiver (father). This report was filed in our complaint handling system as complaint # (b)(4). Rupture artery is a potential complication of a fundoplication surgical procedure. There is no clear causal relationship between the use of the vest and the rupture of the artery. There was no evidence of a malfunction and the device performed as intended. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: D, B5
[11755854]
At the hospital the patient's blood pressure was 60/30 and he was transfused with three units of blood. Emergency laparoscopic surgery was performed to repair a torn artery in hi abdomen. The patient was approximately two weeks status post fundoplication. He has a history of being special needs, seizure disorder and gerd. He was using the vest for pulmonary issues related to the gerd. Medications include miralax and several anticonvulsants. The vest has been in use since (b)(6) 2013. A hill-rom representative called the patient's father to discuss the allegation of an artery rupturing. The father stated that in his doctor's report states that the vest caused the rupture. His son is a special needs (b)(6) old boy and has not been the same since this incident. The father did state that he does not give the vest treatments but this was also not the first time his son has used the vest. The father would not rerelease any further information till he seeks legal counsel. The vest has not been used since the incident. The vest was sent back to hill-rom for investigation and the engineering investigation concluded that the vest passed all performance testing and did function as design.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008145987-2014-00003 |
| MDR Report Key | 3800231 |
| Report Source | 04 |
| Date Received | 2014-04-30 |
| Date of Report | 2014-03-31 |
| Date of Event | 2014-01-20 |
| Date Mfgr Received | 2014-03-31 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2014-05-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JENNIFER MORRIS |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 8129313121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTROLLER, VEST 105 |
| Generic Name | THE VEST |
| Product Code | BYI |
| Date Received | 2014-04-30 |
| Model Number | P105CM |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2014-04-30 |