MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-02-14 for VEST MODEL P105A manufactured by Hillrom Singapore.
[4204808]
Hill-rom received a report from a patient stating that her right lung collapsed after using the vest. The report from the patient indicates she was trained on a wrap garment and given the prescribed setting. The garment was changed out by her hct, to a full garment but they did not provide her the settings too use, so she used the settings for the wrap. This report was filed in our complaint handling system as complaint #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11678649]
Development of secondary spontaneous pneumothoraces (ssps), by definition, occurs in individuals with significant underlying lung disease and cannot only be attributed to performance of the vest. The most common underlying lung disease is chronic obstructive pulmonary disease (copd). , which accounts for approximately 70% of cases. This patient in particular had a number of chronic pulmonary conditions including asthma, conchitis, copd, pneumonia, and mycobacterium avium intracellulare. Investigation indicated that there was no evidence of a device malfunction or a failure to meet specification. The unit was brought back and inspected and no problems were found. The patient stated she had a procedure to "reglue" her lung. Imaging studies performed on (b)(6) 2013, show no pneumothorax as it had resolved.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008145987-2014-00001 |
| MDR Report Key | 3644352 |
| Report Source | 07 |
| Date Received | 2014-02-14 |
| Date of Report | 2014-01-16 |
| Date of Event | 2013-07-02 |
| Date Mfgr Received | 2013-07-08 |
| Date Added to Maude | 2014-02-26 |
| 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 | 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VEST MODEL |
| Generic Name | THE VEST |
| Product Code | BYI |
| Date Received | 2014-02-14 |
| Model Number | P105A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILLROM SINGAPORE |
| Manufacturer Address | NORTH EAST SINGAPORE 768923 SN 768923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-14 |