MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-06-19 for CONTROLLER, VEST 105 P105CM manufactured by Singapore.
[4678417]
The patient's husband called wanting a pickup of the vest from a clinical staff member and reported that his wife suffered fractures in her back from the vest. He stated that his wife has severe osteoporosis. The husband stated his wife's lung doctor stated that she could not have surgery due to her respiratory condition is too bad, the patient is in the final stages of copd. (b)(4). The device s/n (b)(4) was delivered to hill-rom engineering without the actual garment used it the alleged incident. The device did not have a reported condition. There were no visual indications of damage to the device and no abnormal error codes in memory. The device powered up normally and completed a therapy session at 20hz 10i 20min. The pressure specifications will be verified on the manufacturing eol tester. The device performed as intended. Based on this information, no further action is required. Patient's fractures are most likely related to her underlying pathology and not the use of the vest. There as no evidence of the malfunction and the device performed as intended. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: D, B5
[12027817]
A hill-rom representative called the patient to ask about the allegation of fractures in her back. The patient stated that she believed the vest caused the fractures in her back. She stated she did not have any problems with her back before using the vest. She did go to the doctor and had x-rays that showed the multiple fractures. She was prescribed pain killers. The patient confirmed she did suffer from severe osteoporosis and has since returned the vest to hill-rom. A hill-rom representative spoke with the patient's clinical manger at northeast michigan pulmonary associates to ask if there was ny additional information regarding the allegation of a patient fracturing her ribs. The hill-rom representative was unable to peak directly to the prescribing physician. Three attempts have been made to the account regarding the allegation of a patient fracturing her ribs without obtaining any information. Therefore the clinical investigation will be closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008145987-2014-00006 |
| MDR Report Key | 3894238 |
| Report Source | 04,07 |
| Date Received | 2014-06-19 |
| Date of Report | 2014-05-28 |
| Date of Event | 2013-12-18 |
| Date Mfgr Received | 2014-05-28 |
| Date Added to Maude | 2014-07-17 |
| 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 | 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 | 2014-06-19 |
| Model Number | P105CM |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SINGAPORE |
| Manufacturer Address | NORTH EAST SINGAPORE 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-19 |